Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
October 19, 2023 update: 171 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. Of those newly added to the list, 155 are devices with final decision dates between August 1, 2022, and July 30, 2023, and 16 are devices from prior periods identified through a refinement of methods used to generate this list.
As technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices. One of the greatest potential benefits of AI/ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of health care every day. Digital health technologies are playing an increasingly significant role in many facets of our health and daily lives, and AI/ML is powering important advancements in this field. Ensuring that these innovative devices are safe and effective, and that they can reach their full potential to help people, is central to the FDA's public health mission.
Interest in medical devices incorporating AI/ML functionality has increased in recent years and even more so in recent months due to the development of large language models (LLMs). LLMs are AI models that are trained on very large datasets, enabling them to recognize, summarize, translate, predict, and generate content (for example: ChatGPT, Llama, Claude, PaLM, etc.). Over the past decade, the FDA has reviewed and authorized a growing number of devices (marketed via 510(k) clearance, granted De Novo request, or premarket approval) with AI/ML across many different fields of medicine—and expects this trend to continue. As of October 19, 2023, no device has been authorized that uses generative AI or artificial general intelligence (AGI) or is powered by large language models.
The FDA is providing this list and insights of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.
Contents of this list: This list contains publicly available information on AI/ML-enabled devices. The FDA compiled this list from the FDA’s publicly-facing information, including public-facing summaries and AI/ML specific product codes, as well as information in the publicly available resources cited below (*) and in other publicly available materials published by the specific manufacturers.
This list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. Rather, it is a list of medical devices that incorporate AI/ML across medical disciplines, primarily based on information provided in the summary descriptions of their marketing authorization document.
Insights from this list: The insights regarding submission trends that are highlighted below were generated using both publicly available information provided in the summary descriptions of their marketing authorization document and certain aggregated information from internal sources. Public-facing summaries are not all inclusive and do not include the majority of information that may be submitted in the full submission, which is often thousands if not tens of thousands of pages. Additionally, the majority of summaries are written by the submitter of the application and reflect what they consider important, which may not include AI/ML methods and other information used to generate these insights about general trends.
- The year-over-year increase of AI/ML-enabled devices slowed in 2021 (15%) and 2022 (14%) after an increase of 39% in 2020 (compared to 2019). Based on projected volume in 2023, the increase of AI/ML-enabled devices (compared to 2022) is expected to reach 30+%.
- 87% of devices on this list authorized in calendar year 2022 are in Radiology (122), followed by 7% in Cardiovascular (10) and 1% each in Neurology (2), Hematology (1), Gastroenterology/Urology (1), Ophthalmic (2), Clinical Chemistry (1) and Ear, Nose and Throat (1).
- Through the end of July 2023, 79% of devices authorized in 2023 are in Radiology (85), 9% in Cardiovascular (10), 5% in Neurology (5), 4% in Gastroenterology/Urology (4), 2% in Anesthesiology (2), and 1% each in Ear, Nose and Throat (1), and Ophthalmic (1).
- In addition to having the largest number of submissions, Radiology has experienced the steadiest increase of AI/ML-enabled device submissions of any specialty.
- In general, machine learning models have ranged in complexity from shallow (less than two hidden layers) models to more complex models (deep learning models).
- Models have generally trended toward more hybrid approaches, combining different algorithmic approaches to achieve the result of a safe and effective device (for example, using one model to generate features, and using another model to do classification).
Updates to this list: The FDA plans to update this list on a periodic basis based on publicly available information. Send questions or feedback on this list to digitalhealth@fda.hhs.gov.
AI/ML-Enabled Medical Devices
This list contains publicly available information on AI/ML-enabled devices.
Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.
Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA's publicly available information.
Date of Final Decision | Submission Number | Device | Company | Panel (Lead) | Primary Product Code |
---|---|---|---|---|---|
07/29/2022 | K213760 | ABMD Software | HeartLung Corporation | Radiology | KGI |
07/29/2022 | K220961 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | Radiology | JAK |
07/28/2022 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging Inc | Radiology | QIH |
07/28/2022 | K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | Radiology | LNH |
07/27/2022 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular | DQK |
07/25/2022 | K220439 | Viz SDH | Viz.ai, Inc. | Radiology | QAS |
07/22/2022 | K220624 | AI4CMR v1.0 | AI4MedImaging Medical Solutions S.A. | Radiology | LLZ |
07/22/2022 | K220882 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and | Radiology | IYN |
07/22/2022 | K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | QIH |
07/20/2022 | K220956 | Libby Echo:Prio | Dyad Medical, Inc | Radiology | QIH |
07/19/2022 | K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | Cardiovascular | DXH |
07/19/2022 | K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | Cardiovascular | DQK |
07/19/2022 | K220815 | BrainInsight | Hyperfine, Inc. | Radiology | QIH |
07/18/2022 | K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
07/18/2022 | K221148 | Vivid iq | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | Radiology | IYN |
07/15/2022 | K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
07/13/2022 | K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
07/08/2022 | K212783 | ProstatID | ScanMed, LLC | Radiology | QDQ |
07/06/2022 | K210069 | Minuteful - kidney test | Healthy.io Ltd. | Clinical Chemistry | JIR |
06/29/2022 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | Cardiovascular | DQD |
06/29/2022 | K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
06/27/2022 | K220848 | Venue Fit | GE Medical Systems | Radiology | IYN |
06/27/2022 | K220851 | Venue | GE Medical Systems | Radiology | IYN |
06/23/2022 | K220497 | CoLumbo | Smart Soft Healthcare AD | Radiology | QIH |
06/21/2022 | K220800 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
06/17/2022 | K213037 | IDx-DR v2.3 | Digital Diagnostics Inc. | Ophthalmic | PIB |
06/17/2022 | K220813 | ART-PLAN | TheraPanacea | Radiology | QKB |
06/17/2021 | K203514 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK |
06/16/2021 | K202718 | Qmenta Care Platform Family | Mint Labs, Inc., D/B/A. QMENTA | Radiology | LLZ |
06/16/2022 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | Radiology | JAK |
06/11/2021 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Cardiovascular | MXD |
06/10/2022 | K221393 | Swoop Portable MR Imaging System | Hyperfine, Inc. | Radiology | LNH |
06/10/2021 | K203629 | IDx-DR | Digital Diagnostics Inc. | Ophthalmic | PIB |
06/08/2022 | K213717 | AIR Recon DL | GE Medical Systems,LLC (GE Healthcare) | Radiology | LNH |
06/08/2022 | K213882 | EarliPoint System | EarliTec Diagnostics, Inc. | Neurology | QPF |
06/06/2022 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
06/03/2022 | K213971 | Atrial Fibrillation History Feature | Apple Inc. | Cardiovascular | QDB |
06/03/2022 | K221314 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
06/02/2022 | K220164 | Rayvolve | AZmed SAS | Radiology | QBS |
06/02/2021 | DEN200069 | Cognoa Asd Diagnosis Aid | Cognoa, Inc. | Neurology | QPF |
05/31/2022 | K220766 | eMurmur Heart AI | CSD Labs GmbH | Cardiovascular | DQD |
05/25/2022 | K220416 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
05/19/2021 | K210237 | CINA CHEST | Avicenna.AI | Radiology | QAS |
05/17/2022 | K220499 | Rapid PE Triage and Notification (PETN) | iSchemaView Inc. | Radiology | QAS |
05/17/2022 | K221219 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
05/17/2022 | K221240 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
05/16/2022 | K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | Radiology | LNH |
05/13/2022 | K221106 | Quantib Prostate | Quantib BV | Radiology | LLZ |
05/12/2022 | K220105 | Saige-Dx | DeepHealth, Inc. | Radiology | QDQ |
05/11/2022 | K220446 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
05/10/2022 | K212519 | Overjet Caries Assist | Overjet, Inc. | Radiology | MYN |
05/06/2022 | K211966 | Segment 3DPrint | Medviso AB | Radiology | LLZ |
05/03/2022 | K212915 | MVision AI Segmentation | MVision AI | Radiology | QKB |
05/03/2022 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs Ltd. | Hematology | JOY |
04/30/2021 | K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | KPS |
04/29/2022 | K220590 | aPROMISE X | EXINI Diagnostics AB | Radiology | LLZ |
04/29/2022 | K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | Siemens Medical Solutions USA Inc. | Radiology | LNH |
04/28/2022 | K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.AI Co., Ltd. | Radiology | QKB |
04/27/2022 | K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK |
04/26/2022 | K212662 | AliveCor QT Service | AliveCor, Inc. | Cardiovascular | DQK |
04/26/2022 | K213886 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
04/23/2021 | K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | Canon Medical Systems Corporation | Radiology | KPS |
04/23/2021 | K203502 | MEDO-Thyroid | MEDO DX Pte. Ltd. | Radiology | QIH |
04/22/2022 | K213944 | HealthOST | NanoxAI Ltd. | Radiology | JAK |
04/21/2022 | K213795 | Videa Caries Assist | VideaHealth, Inc | Radiology | MYN |
04/21/2021 | K210556 | Preview Shoulder | Genesis Software Innovations | Radiology | QIH |
04/20/2021 | K203610 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | Radiology | QKB |
04/19/2021 | K203469 | AI Segmentation | Varian Medical Systems | Radiology | MUJ |
04/16/2021 | K203517 | Saige-Q | DeepHealth, Inc. | Radiology | QFM |
04/15/2022 | K213706 | AI-Rad Companion Brain MR | Siemens Healthcare GmBh | Radiology | QIH |
04/15/2022 | K220141 | RayStation 11B | RaySearch Laboratories AB (publ) | Radiology | MUJ |
04/14/2021 | K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical, Ltd. | Radiology | QFM |
04/09/2021 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - AI, Ltd. | Gastroenterology-Urology | QNP |
04/08/2022 | K212274 | INT Contour | Carina Medical LLC | Radiology | MUJ |
04/08/2022 | K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Radiology | LNH |
04/06/2022 | K203783 | ClariPulmo | ClariPi Inc. | Radiology | LLZ |
04/05/2022 | K214081 | MRCAT Head & Neck | Philips Oy | Radiology | MUJ |
04/04/2022 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune. AI Co., Ltd. | Radiology | QIH |
04/02/2021 | K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | Radiology | MQB |
04/01/2022 | K213657 | DEEPVESSEL FFR | KeyaMed NA Inc. | Cardiovascular | PJA |
04/01/2021 | DEN200038 | Gili Pro Biosensor (Also Known as Gili Biosensor System) | Continuse Biometrics Ltd. | Cardiovascular | QOK |
03/31/2021 | K203258 | syngo.CT Lung CAD (Version VD20) | Siemens Healthcare GmbH | Radiology | OEB |
03/31/2021 | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with syngo MR XA31A | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
03/31/2021 | K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | Radiology | LLZ |
03/26/2021 | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | Cardiovascular | QME |
03/24/2021 | K203225 | AquilionONE(TSX‐306A/3)V10.4withSpectralImagingSystem | CanonMedicalSystemsCorporation | Radiology | JAK |
03/23/2021 | K210209 | Viz ICH | Viz.Ai, Inc. | Radiology | QAS |
03/22/2022 | K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | Radiology | IYN |
03/21/2022 | K213721 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
03/19/2021 | K203235 | VBrain | Vysioneer Inc. | Radiology | QKB |
03/14/2022 | K203744 | Arterys MICA | Arterys Inc. | Radiology | QIH |
03/14/2022 | K214043 | BriefCase | Aidoc Medical, Ltd. | Radiology | QFM |
03/11/2022 | K213725 | CardIQ Suite | GE Medical Systems SCS | Radiology | JAK |
03/10/2022 | K213566 | ClearRead Xray Pneumothorax | Riverain Technologies, Inc. | Radiology | QFM |
03/09/2021 | K203256 | Imbio RV/LV Software | Imbio, LLC | Radiology | QIH |
03/05/2021 | K202300 | Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform | Optellum Ltd | Radiology | POK |
03/04/2022 | K210365 | Second Opinion | Pearl Inc. | Radiology | MYN |
03/01/2022 | K212365 | BoneView | Gleamer | Radiology | QBS |
03/01/2021 | DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye Inc. | Cardiovascular | QNV |
02/25/2021 | K202990 | NinesMeasure | Nines, Inc. | Radiology | LLZ |
02/25/2021 | K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imaging AI, Inc. | General And Plastic Surgery | NQQ |
02/25/2022 | K213693 | MAGNETOM Vida with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
02/24/2022 | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-AI | Radiology | QFM |
02/19/2021 | K202212 | Truplan | Circle Cardiovascular Imaging Inc. | Radiology | LLZ |
02/18/2022 | K213319 | Viz ANEURYSM, Viz ANX | Viz.ai, Inc. | Radiology | QFM |
02/18/2022 | K213999 | Deep Learning Image Reconstruction | GE Medical Systems | Radiology | JAK |
02/09/2021 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | Radiology | LLZ |
02/08/2022 | K213165 | Rapid | iSchema View Inc. | Radiology | LLZ |
02/05/2021 | K210053 | LVivo Software Application | DiA Imaging Analysis Ltd. | Radiology | QIH |
02/04/2022 | K212654 | Micro C Medical Imaging System, M01 | OXOS Medical, Inc. | Radiology | IZL |
02/04/2022 | K213938 | Revolution Ascend | GE Healthcare Japan Corporation | Radiology | JAK |
02/03/2022 | K213976 | Contour ProtegeAI | MIM Software Inc. | Radiology | QKB |
01/29/2021 | K201411 | Visage Breast Density | Visage Imaging GmbH | Radiology | QIH |
01/15/2021 | K193271 | UAI Easytriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | QFM |
01/14/2021 | K202700 | ART-Plan | TheraPanacea | Radiology | QKB |
01/12/2021 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 With AiCE-I | Canon Medical Systems Corporation | Radiology | JAK |
01/09/2021 | K200717 | CLEWICU System (ClewICUserver and ClewICUnitor) | Clew Medical Ltd. | Cardiovascular | QNL |
01/07/2021 | K202414 | BrainInsight | Hyperfine Research, Inc. | Radiology | LLZ |
12/29/2020 | K203508 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
12/22/2020 | K202229 | AI Metrics | AI Metrics, LLC | Radiology | LLZ |
12/18/2020 | K201555 | EchoGo Pro | Ultromics Ltd. | Radiology | POK |
12/10/2020 | K201745 | Deep Learning Image Reconstruction For Gemstone Spectral Imaging | GE Medical Systems, LLC | Radiology | JAK |
12/10/2020 | K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 With AiCE-I | Canon Medical Systems Corporation | Radiology | JAK |
12/07/2020 | K201039 | HepaFat-AI | Resonance Health Analysis Services Pty Ltd. | Radiology | LNH |
12/04/2020 | K202487 | HealthJOINT | Zebra Medical Vision Ltd. | Radiology | LLZ |
11/20/2020 | K200873 | HALO | NICo-Lab B.V. | Radiology | QAS |
11/20/2020 | K203169 | Revolution Ascend | GE Healthcare Japan Corporation | Radiology | JAK |
11/20/2020 | K193287 | CorInsights MRI | ADM Diagnostics | Radiology | LLZ |
11/18/2020 | K201019 | Genius AI Detection | Hologic, Inc. | Radiology | QDQ |
11/17/2020 | K193306 | PROView | GE Medical Systems SCS | Radiology | LLZ |
11/12/2020 | K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | Radiology | JAK |
11/06/2020 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | Radiology | QKB |
11/06/2020 | K200750 | Neuro.Al Algorithm | TeraRecon, Inc. | Radiology | LLZ |
10/30/2020 | K200323 | Autocontour | Radformation, Inc. | Radiology | QKB |
10/30/2020 | K202013 | WRDensity by Whiterabbit.ai | Whiterabbit.ai Inc. | Radiology | QIH |
10/28/2020 | K202089 | Lenshooke X1 Pro Semen Quality Analyzer, Lenshooke X1 Pro Se Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology | POV |
10/16/2020 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | Hematology | JOY |
10/16/2020 | K201710 | A View LCS | Coreline Soft Co., Ltd. | Radiology | LLZ |
10/11/2020 | K202501 | Quantib Prostate | Quantib BV | Radiology | LLZ |
10/09/2020 | K193631 | Stethee Pro 1, Stethee Pro Software System | M3DICINE Pty Ltd. | Cardiovascular | DQD |
10/02/2020 | K201301 | X100 With Full Field Peripheral Blood Smear (Pbs) Application | Scopio Labs Ltd. | Hematology | JOY |
10/02/2020 | K202280 | Cleerly Labs V2.0 | Cleerly, Inc. | Radiology | LLZ |
10/02/2020 | K202170 | LiverMultiScan | Perspectum Ltd. | Radiology | LNH |
09/30/2020 | K192051 | THINQ | CorticoMetrics LLC | Radiology | LLZ |
09/25/2020 | K201103 | Xeleris V Processing And Review Systems | GE Healthcare | Radiology | LLZ |
09/24/2020 | K200569 | Raystation | Raysearch Laboratories Ab (Publ) | Radiology | MUJ |
09/18/2020 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | LLZ |
09/18/2020 | K201992 | Caption Guidance | Caption Health | Radiology | QJU |
09/16/2020 | K201298 | VX1 | Volta Medical | Cardiovascular | DQK |
09/16/2020 | K201369 | AVA (Augmented Vascular Analysis) | See-Mode Technologies Pte. Ltd. | Radiology | LLZ |
09/15/2020 | K192665 | Accelerate Pheno System, Accelerate Phenotest Bc Kit | Accelerate Diagnostics, Inc. | Microbiology | PRH |
09/09/2020 | K200708 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
09/09/2020 | K200851 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
09/02/2020 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | Cardiovascular | MLO |
08/26/2020 | K200714 | AVIEW | Coreline Soft Co., Ltd. | Radiology | LLZ |
08/26/2020 | K201020 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
08/14/2020 | K201632 | Tomtec-Arena | Tomtec Imaging Systems Gmbh | Radiology | LLZ |
08/13/2020 | K201232 | Limbus Contour | Limbus Ai Inc. | Radiology | LLZ |
08/13/2020 | K201444 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Radiology | MUJ |
08/07/2020 | K200990 | Vida|Vision | Vida Diagnostics Inc. | Radiology | JAK |
08/07/2020 | K201310 | Accipiolx | MaxQ Al Ltd. | Radiology | QAS |
08/04/2020 | K193210 | HYPER DLR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
08/03/2020 | K200667 | EyeArt | Eyenuk, Inc | Ophthalmic | PIB |
07/30/2020 | K193283 | AI-Rad Companion Prostate MR | Siemens Medical Solutions USA Inc | Radiology | QIH |
07/30/2020 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | Radiology | QBS |
07/23/2020 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
07/22/2020 | K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | Radiology | QIH |
07/16/2020 | K200497 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
07/16/2020 | K200905 | HealthMammo | Zebra Medical Vision Ltd. | Radiology | QFM |
07/14/2020 | K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 With AiCE Reconstruction Processing Unit For MR | Canon Medical Systems Corporation | Radiology | LNH |
07/10/2020 | K192969 | Ezra Plexo Software | Ezra AI Inc. | Radiology | QIH |
07/10/2020 | K193294 | AI-Rad Companion Engine | Siemens Medical Solutions USA, Inc. | Radiology | LLZ |
07/06/2020 | K193073 | Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK |
07/02/2020 | K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co.,Ltd. | Radiology | OEB |
07/02/2020 | K193252 | Contour ProtégéAI | MIM Software, Inc. | Radiology | QKB |
06/26/2020 | K200760 | Rapid ASPECTS | ISchemaView Inc. | Radiology | POK |
06/24/2020 | K200855 | CINA | AVICENNA.AI | Radiology | QAS |
06/23/2020 | K200232 | LVivo Software Application | DiA Imaging Analysis Ltd | Radiology | QIH |
06/19/2020 | K193298 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
06/17/2020 | K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | Radiology | LLZ |
06/17/2020 | K200921 | QER | Qure.Ai Technologies | Radiology | QAS |
06/11/2020 | K200356 | MEDO ARIA | MEDO.ai | Radiology | QIH |
06/11/2020 | K200980 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | Radiology | IYO |
05/12/2020 | K192901 | HealthVCF | Zebra Medical Vision Ltd. | Radiology | QFM |
05/05/2020 | K193176 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH |
05/05/2020 | K193220 | AVIEW LCS | Coreline Soft Co., Ltd | Radiology | LLZ |
04/21/2020 | K193351 | NinesAI | Nines, Inc. | Radiology | QAS |
04/16/2020 | K200755 | Caption Guidance | Caption Health, Inc. | Radiology | QJU |
04/13/2020 | K192167 | CuraRad-ICH | CuraCloud Corp. | Radiology | QAS |
04/10/2020 | K193282 | Signa Premier | GE Healthcare (GE Medical Systems, LLC) | Radiology | LNH |
04/08/2020 | K193300 | AIMI-Triage CXR PTX | RADLogics, Inc. | Radiology | QFM |
03/31/2020 | K193087 | Rapid ICH | ISchemaView Incorporated | Radiology | QAS |
03/26/2020 | K192732 | Bodyguardian Remote Monitoring System | Preventice Technologies, Inc. | Cardiovascular | DSI |
03/26/2020 | K193518 | KOSMOS | EchoNous, Inc. | Radiology | IYN |
03/25/2020 | K192437 | Arterys MICA | Arterys Inc. | Radiology | QIH |
03/25/2020 | K192854 | MammoScreen | Therapixel | Radiology | QDQ |
03/20/2020 | K193281 | Hepatic VCAR | GE Medical Systems SCS | Radiology | JAK |
03/20/2020 | K200036 | AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. | Cardiovascular | DPS |
03/18/2020 | K193658 | Viz ICH | Viz.Ai, Inc. | Radiology | QAS |
03/16/2020 | K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
03/12/2020 | K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | Radiology | IYN |
03/09/2020 | K192574 | Vantage Galan 3T, MRT-3020, V6.0 With AiCE Reconstruction Processing Unit For MR | Canon Medical Systems Corporation | Radiology | LNH |
03/09/2020 | K193216 | Syngo.CT Lung CAD | Siemens Medical Solutions, Inc | Radiology | OEB |
03/05/2020 | K193229 | Transpara | Screenpoint Medical B.V. | Radiology | QDQ |
03/04/2020 | K191550 | Broncholab | Fluidda Inc. | Radiology | JAK |
02/28/2020 | K191556 | Red Dot | Behold.AI Technologies Limited | Radiology | QFM |
02/28/2020 | K191928 | AccuContour | Xiamen Manteia Technology Ltd. | Radiology | QKB |
02/28/2020 | K192962 | icobrain-ctp | icometrix NV | Radiology | LLZ |
02/21/2020 | K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-I | Canon Medical Systems Corporation | Radiology | JAK |
02/19/2020 | K192973 | Densitas Densityai | Densitas, Inc. | Radiology | LLZ |
02/14/2020 | K193248 | Biograph Vision, Biograph MCT Family Of PET/CTs | Siemens Medical Solutions USA, Inc. | Radiology | KPS |
02/13/2020 | K192828 | Aquilion ONE (TSX-306A/3) V10.0 With Spectral Imaging System | Canon Medical Systems Corporation | Radiology | JAK |
02/12/2020 | K193178 | Biograph Horizon PET/CT | Siemens Medical Solution USA, Inc. | Radiology | KPS |
02/10/2020 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. | Radiology | IYE |
02/07/2020 | DEN190040 | Caption Guidance | Bay Labs, Inc. | Radiology | QJU |
01/24/2020 | K193109 | MRCAT Brain | Philips Medical Systems MR Finland | Radiology | MUJ |
01/16/2020 | K192956 | Auto Positioning | GE Hangwei Medical Systems, Co., Ltd. | Radiology | JAK |
01/15/2020 | K191125 | ADAS 3D | Galgo Medical S.L | Radiology | LLZ |
01/15/2020 | K192004 | Eko Analysis Software | Eko Devices Inc | Cardiovascular | MWI |
01/02/2020 | K183089 | Air Next | NuvoAir AB | Anesthesiology | BZG |
12/20/2019 | K191647 | Qlab Advanced Quantification Software | Philips Healthcare | Radiology | QIH |
12/20/2019 | K192383 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
12/17/2019 | K192763 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
12/13/2019 | K192531 | QyScore Software | Qynapse | Radiology | LLZ |
12/13/2019 | K193170 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | Radiology | JAK |
12/13/2019 | K192130 | icobrain | icometrix NV | Radiology | LLZ |
12/11/2019 | K192571 | NemoScan | Software Nemotec S.L. | Radiology | LLZ |
12/10/2019 | K192287 | Transpara | Screenpoint Medical B.V. | Radiology | QDQ |
12/09/2019 | K192442 | FFRangio | CathWorks Ltd | Cardiovascular | QEK |
12/07/2019 | K192279 | PhantomMSK Trauma | OrthoGrid Systems Inc. | Radiology | LLZ |
11/27/2019 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical Inc. | Neurology | HAW |
11/26/2019 | K192320 | HealthCXR | Zebra Medical Vision Ltd. | Radiology | QFM |
11/25/2019 | K190529 | SOZO | ImpediMed Limited | Gastroenterology-Urology | QJB |
11/19/2019 | K191278 | RSI-MRI+ | Multimodal Imaging Services Corporation (Dba HealthLytix) | Radiology | LLZ |
11/13/2019 | K191171 | EchoGo Core | Ultromics Ltd. | Radiology | QIH |
11/07/2019 | K191026 | MEDIP PRO | MEDICAL IP Co., Ltd. | Radiology | LLZ |
11/05/2019 | K190868 | Cleerly Labs | Cleerly Inc | Radiology | LLZ |
11/05/2019 | K192109 | Koala | IB Lab Gmbh | Radiology | LLZ |
11/04/2019 | K190013 | WellDoc BlueStar | WellDoc, Inc | General Hospital | MRZ |
11/01/2019 | K190334 | MIMOSA Imager | MIMOSA Diagnostics Inc. | General And Plastic Surgery | MUD |
11/01/2019 | K190898 | Sight OLO | Sight Diagnostics Ltd. | Hematology | GKZ |
10/18/2019 | K183274 | RTHawk, HeartVista Cardiac Package | HeartVista, Inc. | Radiology | LNH |
10/17/2019 | K192455 | Merge PACS | Merge Healthcare Incorporated | Radiology | LLZ |
10/16/2019 | K191493 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics Ltd. | Radiology | LLZ |
10/04/2019 | K191713 | CS-Series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield¿ (ROI Assembly) | Omega Medical Imaging, LLC | Radiology | JAA |
10/04/2019 | K191994 | ProFound AI Software V2.1 | ICAD Inc. | Radiology | QDQ |
09/18/2019 | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | Radiology | MUJ |
09/16/2019 | K191688 | SubtleMR | Subtle Medical Inc. | Radiology | LLZ |
09/13/2019 | K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | Radiology | LLZ |
09/11/2019 | K183370 | PeraMobile and PeraWatch | PeraHealth, Inc. | Cardiovascular | MWI |
09/11/2019 | K190815 | Brainscope TBI | BrainScope Company, Inc. | Neurology | PIW |
09/10/2019 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
09/04/2019 | K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | Neurology | GXY |
08/29/2019 | K183489 | D2P | 3D Systems, Inc. | Radiology | LLZ |
08/29/2019 | K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | Radiology | IYN |
08/15/2019 | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte. Ltd | Cardiovascular | PLB |
08/15/2019 | K190925 | HeartfFow FFRct Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
08/12/2019 | K183182 | Critical Care Suite | GE Medical Systems, LLC | Radiology | QFM |
08/05/2019 | K191262 | ABSI | EXINI Diagnostics AB | Radiology | LLZ |
07/26/2019 | K182384 | ACR | LAB Urine Analysis Test System | Healthy.Io Ltd | Clinical Chemistry | JFY |
07/26/2019 | K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
07/19/2019 | K182798 | KIDScore D3 | Vitrolife A/S | Obstetrics And Gynecology | PBH |
07/12/2019 | K191585 | INtuition-Structural Heart Module | TeraRecon Inc. | Radiology | LLZ |
07/10/2019 | K182875 | DeepCT | Deep01 Limited | Radiology | QAS |
07/10/2019 | K183322 | PhysIQ Heart Rhythm and Respiratory Module | PhysIQ, Inc | Cardiovascular | DPS |
07/08/2019 | K191384 | RayCare 2.3 | RaySearch Laboratories AB (Publ) | Radiology | MUJ |
07/05/2019 | K182901 | Aquilion Precision (TSX-304A/1 And /2) V8.8 With AiCE | Canon Medical Systems Corporation | Radiology | JAK |
07/03/2019 | K190442 | Koios DS For Breast | Koios Medical, Inc. | Radiology | POK |
06/27/2019 | K190017 | Livermultiscan (LMSv3) | Perspectum Diagnostics Ltd | Radiology | LNH |
06/25/2019 | K191194 | CLARUS | Carl Zeiss Meditec, Inc | Ophthalmic | QER |
06/19/2019 | K190387 | Raystation | Raysearch Laboratories Ab (Publ) | Radiology | MUJ |
06/13/2019 | K183460 | ClariCT AI | ClariPI Inc. | Radiology | LLZ |
06/13/2019 | K190424 | Healthich | Zebra Medical Vision Ltd. | Radiology | QAS |
06/12/2019 | K183046 | Aquilion ONE (TSX-305A/6) V8.9 With AiCE | Canon Medical Systems Corporation | Radiology | JAK |
05/31/2019 | K190896 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
05/24/2019 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | Neurology | GXY |
05/21/2019 | K183646 | Acumen Hypotension Prediction Index - EV1000 Clinical Platform, Acumen Hypotension Prediction Index - Hemosphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index, Hemosphere Advanced Monitoring Platform - Pressure | Edwards Lifeciences, LLC | Cardiovascular | QAQ |
05/15/2019 | K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems AG | Microbiology | PPU |
05/13/2019 | K190764 | SurgicalAR | MEDIVIS, Inc. | Radiology | LLZ |
05/06/2019 | K190362 | HealthPNX | Zebra Medical Vision Ltd. | Radiology | QFM |
04/22/2019 | K182513 | FluChip-8G Influenza A+B Assay | InDevR, Inc. | Microbiology | OZE |
04/18/2019 | K183593 | Lung Vision System | Body Vision Medical Ltd. | Radiology | LLZ |
04/17/2019 | K181988 | EMurmur ID | CSD Labs GmbH | Cardiovascular | DQD |
04/15/2019 | K190072 | Briefcase | Aidoc Medical, Ltd. | Radiology | QAS |
04/12/2019 | K183202 | Deep Learning Image Reconstruction | GE Medical Systems, LLC | Radiology | JAK |
04/08/2019 | K183204 | Bone VCAR (BVCAR) | GE Medical Systems SCS | Radiology | JAK |
03/29/2019 | K181352 | Loop System | Spry Health, Inc. | Cardiovascular | DQA |
03/19/2019 | K183019 | SIS Software Version 3.3.0 | Surgical Information Sciences, Inc. | Radiology | LLZ |
03/11/2019 | K181823 | KardiaAI | AliveCor, Inc. | Cardiovascular | DQK |
03/08/2019 | K183285 | Cmtriage | Curemetrix, Inc | Radiology | QFM |
03/07/2019 | K182344 | RhythmAnalytics | Biofourmis Singapore Pte. Ltd. | Cardiovascular | DQK |
02/16/2019 | K183704 | Rx-1 Rhythm Express Remote Cardiac Monitoring System | Vivaquant Inc. | Cardiovascular | DXH |
02/04/2019 | K181916 | D-Nav System | Hygieia, Inc | General Hospital | NDC |
02/01/2019 | K183272 | AI Rad Companion (Engine) | Siemens Medical Solutions USA, Inc. | Radiology | LLZ |
01/18/2019 | K183231 | SIGNA Premier | GE Medical Systems, LLC | Radiology | LNH |
01/17/2019 | K182456 | Study Watch | Verily Life Sciences Llc | Cardiovascular | DXH |
01/09/2019 | K183133 | MRCP+ V1.0 | Perspectum Diagnostics Ltd | Radiology | LLZ |
12/28/2018 | DEN170091 | EyeBOX | Oculogica, Inc. | Neurology | QEA |
12/28/2018 | K180867 | AmCAD-UO | AmCad BioMed Corporation | Radiology | LLZ |
12/27/2018 | K182130 | ISchemaView RAPID | ISchemaView, Inc. | Radiology | LLZ |
12/27/2018 | K182564 | Quantib ND | Quantib BV | Radiology | LLZ |
12/21/2018 | K183012 | VascuCAP | Elucid Bioimaging Inc. | Radiology | LLZ |
12/20/2018 | K181861 | Embrace | Empatica Srl | Neurology | POS |
12/19/2018 | K182149 | FFRangio System | CathWorks Ltd | Cardiovascular | QEK |
12/14/2018 | K182419 | Centricity Universal Viewer | GE Healthcare | Radiology | LLZ |
12/14/2018 | K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix Inc. | Cardiovascular | DPS |
12/06/2018 | K173749 | AMRA Profiler | AMRA Medical AB | Radiology | LNH |
12/06/2018 | K182373 | PowerLook Tomo Detection V2 Software | ICAD Inc. | Radiology | QDQ |
12/06/2018 | K182035 | FFRct v2.18 | HeartFlow, Inc. | Cardiovascular | PJA |
11/30/2018 | K182218 | FerriSmart Analysis System | Resonance Health Analysis Service Pty Ltd. | Radiology | PCS |
11/30/2018 | K182336 | SubtlePET | Subtle Medical, Inc. | Radiology | KPS |
11/29/2018 | K182181 | Persyst 14 EEG Review And Analysis Software | Persyst Development Corporation | Neurology | OMB |
11/21/2018 | K181704 | Transpara | Screenpoint Medical Bv | Radiology | QDQ |
11/20/2018 | K181247 | Vitrea CT Brain Perfusion | Vital Images, Inc. | Radiology | LLZ |
11/19/2018 | K180432 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd. | Cardiovascular | DQK |
11/16/2018 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology | POV |
11/06/2018 | K181939 | icobrain | icometrix NV | Radiology | LLZ |
11/05/2018 | K181288 | Athelas One | Athelas Inc. | Hematology | GKZ |
11/02/2018 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | NinePoint Medical, Inc. | General And Plastic Surgery | NQQ |
10/26/2018 | K182177 | Accipiolx | MaxQ-Al Ltd. | Radiology | QAS |
10/25/2018 | K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
10/17/2018 | K182034 | Arterys MICA | Arterys Inc. | Radiology | LLZ |
10/09/2018 | K181892 | Ziostation2 | Ziosoft, Inc. | Radiology | LLZ |
10/05/2018 | K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | Neurology | GXY |
09/28/2018 | K173872 | FibriCheck | Qompium NV | Cardiovascular | DXH |
09/28/2018 | K181771 | RightEye Vision System | RightEye, LLC | Ophthalmic | GWN |
09/21/2018 | K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | Radiology | LLZ |
08/29/2018 | K181502 | Zio AT ECG Monitoring System, Zeus System | IRhythm Technologies, Inc. | Cardiovascular | DQK |
08/01/2018 | K180647 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
07/23/2018 | K173444 | Quantitative Total Extensible Imaging (QTxi) | AIQ Solutions, Inc. | Radiology | LLZ |
07/18/2018 | K173327 | DIP/U.S. Urine Analysis Test System | Healthy.io Ltd | Clinical Chemistry | JIL |
07/10/2018 | K181572 | Workflow Box | Mirada Medical Ltd. | Radiology | QKB |
07/10/2018 | K181574 | Uscan | EchoNous, Inc. | Radiology | IYO |
06/29/2018 | K180038 | NuVasive Pulse System | NuVasive, Incorporated | Orthopedic | OLO |
06/26/2018 | K173574 | DenSeeMammo | STATLIFE | Radiology | LLZ |
06/14/2018 | K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | Radiology | LLZ |
06/13/2018 | K172983 | HealthCCS | Zebra Medical Vision Ltd. | Radiology | JAK |
06/12/2018 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | Clinical Chemistry | QCC |
06/05/2018 | K173821 | LungQ Software | Thirona Corporation | Radiology | JAK |
05/25/2018 | K180163 | TransEnterix Senhance Surgical System | TransEnterix, Inc | General And Plastic Surgery | NAY |
05/24/2018 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | Radiology | QBS |
05/14/2018 | K173810 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics, Ltd. | Radiology | IYN |
05/14/2018 | K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | Radiology | IYN |
05/02/2018 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
05/01/2018 | K172959 | PeraServer and PeraTrend | PeraHealth, Inc. | Cardiovascular | MWI |
04/20/2018 | K180161 | Viz CTP | Viz.ai, Inc. | Radiology | LLZ |
04/16/2018 | K180126 | SOZO | ImpediMed Limited | Gastroenterology-Urology | OBH |
04/11/2018 | DEN180001 | IDx-DR | IDx, LLC | Ophthalmic | PIB |
04/05/2018 | K180589 | DR 800 With MUSICA Dynamic | Agfa HealthCare N.V. | Radiology | JAA |
03/16/2018 | DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences LLC | Cardiovascular | QAQ |
03/09/2018 | K173939 | Quantib Brain | Quantib BV | Radiology | LLZ |
03/08/2018 | K173605 | IQMR | Medic Vision - Imaging Solutions Ltd | Radiology | LLZ |
02/23/2018 | K170540 | DM-Density | Densitas, Inc. | Radiology | LLZ |
02/13/2018 | DEN170073 | ContaCT | Viz.Al, Inc. | Radiology | QAS |
02/08/2018 | K180091 | UNID Spine Analyzer | Medicrea International | Radiology | LLZ |
01/25/2018 | K173542 | Arterys Oncology Dl | Arterys Inc. | Radiology | LLZ |
01/12/2018 | K173588 | Illumeo System | Philips Medical Systems Technologies, Ltd | Radiology | LLZ |
01/11/2018 | K171122 | CEREC Ortho Software | Dentsply Sirona | Dental | PNN |
01/08/2018 | K171328 | CNeuro CMRI | Combinostics Oy | Radiology | LLZ |
01/04/2018 | K171056 | WAVE Clinical Platform | Excel Medical Electronics, LLC | Cardiovascular | MWI |
12/27/2017 | K173420 | Radiomics App V1.0 | Microsoft Corp. | Radiology | LLZ |
12/22/2017 | K172507 | SOZO | ImpediMed Limited | Cardiovascular | DSB |
11/07/2017 | K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs Ltd. | Cardiovascular | DRG |
10/27/2017 | K172803 | Infinitt PACS 7.0 | Infinitt Healthcare Co.,Ltd. | Radiology | LLZ |
10/20/2017 | K163623 | Quantra | Hologic, Inc. | Radiology | LLZ |
09/27/2017 | K171936 | Peerbridge Cor(TM) System | Peerbridge Health Inc. | Cardiovascular | DSH |
09/15/2017 | K172356 | BladderScan Prime PLUS System | Verathon Incorporated | Radiology | IYO |
09/14/2017 | K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | Radiology | IYN |
09/07/2017 | K170981 | NeuroQuant | CorTechs Labs, Inc | Radiology | LLZ |
08/17/2017 | K163339 | SpectralMD DeepView Wound Imaging System 2.0 | SpectralMD, Inc. | Cardiovascular | DPT |
08/11/2017 | K172122 | SOZO | ImpediMed Limited | Gastroenterology-Urology | OBH |
08/01/2017 | K171315 | Advanced RBC Application | Cella Vision AB | Hematology | JOY |
07/19/2017 | DEN170022 | QuantX | Quantitative Insights, Inc | Radiology | POK |
06/26/2017 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | Cardiovascular | DPS |
06/09/2017 | K170747 | Syngo Application Software | Siemens Medical Solutions, USA, Inc. | Radiology | LLZ |
06/07/2017 | K170250 | SmartTarget | SmarTarget, Ltd. | Radiology | LLZ |
05/24/2017 | K170172 | UNiD Spine Analyzer | Medicrea International | Radiology | LLZ |
05/11/2017 | K163622 | Lung Vision | Body Vision Medical Ltd. | Radiology | LLZ |
05/05/2017 | K163665 | MATRx Plus | Zephyr Sleep Technologies | Anesthesiology | MNR |
04/26/2017 | K170069 | AmCAD-UV | AmCad BioMed Corporation | Radiology | LLZ |
04/06/2017 | DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23andMe, Inc. | Hematology | PTA |
03/31/2017 | K162627 | EnsoSleep | EnsoData, Inc. | Neurology | OLZ |
02/23/2017 | K162855 | Reveal LINQ | Medtronic, Inc. | Cardiovascular | MXD |
02/14/2017 | K162830 | SIS Software | Surgical Information Sciences, Inc. | Radiology | LLZ |
01/06/2017 | K163013 | Quantib Brain 1.2 | Quantib BV | Radiology | LLZ |
01/05/2017 | K163253 | Arterys Cardio DL | Arterys Inc. | Radiology | LLZ |
12/28/2016 | K161959 | ClearView CCAD | ClearView Diagnostics Inc. | Radiology | LLZ |
12/07/2016 | K161322 | CT CoPilot | Zepmed, LLC | Radiology | LLZ |
11/30/2016 | K161834 | One Drop Blood Glucose Monitoring System | AgaMatrix Inc. | Clinical Chemistry | NBW |
11/30/2016 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | Radiology | IYN |
11/09/2016 | P150043 | QVCAD System | QView Medical, Inc. | Radiology | MYN |
10/19/2016 | K160401 | Tyto Stethoscope | Tyto Care Ltd. | Cardiovascular | DQD |
09/22/2016 | K161068 | Ahead 300 | Brainscope Company Inc. | Neurology | PIW |
09/19/2016 | K161625 | PixelShine | AlgoMedica | Radiology | LLZ |
09/09/2016 | K161201 | ClearRead CT | Riverain Technologies, LLC | Radiology | OEB |
08/24/2016 | K161772 | FFRct v2.0 | HeartFlow, Inc. | Cardiovascular | PJA |
08/09/2016 | K161148 | Icobrain | Icometrix | Radiology | LLZ |
08/05/2016 | K160338 | Triton System | Gauss Surgical Inc. | General And Plastic Surgery | PBZ |
07/28/2016 | K161382 | LVivo Software Application | DiACardio, Ltd. | Radiology | LLZ |
07/15/2016 | K160016 | Steth IO | Stratoscientific, Inc. | Cardiovascular | DQD |
07/07/2016 | K160088 | Cydar EV | Cydar Ltd. | Radiology | OWB |
06/17/2016 | K153351 | Quantib Brain 1 | Quantib BV | Radiology | LLZ |
01/13/2016 | K152733 | FFRct | HeartFlow, Inc. | Cardiovascular | PJA |
01/07/2016 | K153427 | Volpara Imaging Software | Matakina Technology Ltd. | Radiology | LLZ |
12/21/2015 | K150817 | Dario Blood Glucose Monitoring System | LabStyle Innovations Ltd. | Clinical Chemistry | NBW |
11/05/2015 | K150102 | SnoreSounds | Appian Medical Inc. | Anesthesiology | MNR |
06/11/2015 | K142512 | Personalized Physiology Analytics Engine Software | VGBio, Inc. (DBA PhysIQ) | Cardiovascular | PLB |
04/24/2015 | K142918 | EndoTool SubQ | Monarch Medical Technologies | General Hospital | NDC |
02/27/2015 | K141922 | IRIS Intelligent Retinal Imaging System | IRIS Intelligent Retinal Imaging Systems, LLC | Ophthalmic | NFJ |
11/17/2014 | DEN140025 | BrainScope Ahead 100 | BrainScope Company, Inc. | Neurology | PIW |
10/10/2014 | K142037 | Quantra | Hologic, Inc. | Radiology | LLZ |
09/17/2014 | K141069 | Lung Density Analysis | Imbio LLC | Radiology | JAK |
08/22/2014 | K141480 | CVI42 | Circle Cardiovascular Imaging Inc | Radiology | LLZ |
04/22/2014 | K133649 | Hepatic VCAR | GE Medical Systems SCS | Radiology | JAK |
01/24/2014 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | Radiology | KPR |
11/21/2013 | K130831 | MALDI Biotyper CA (MBT-CA) System | Bruker Daltonics, Inc. | Microbiology | PEX |
08/21/2013 | DEN130013 | Vitek MS | Biomerieux, Inc. | Microbiology | PEX |
03/22/2013 | K120771 | UniCel DxH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | Hematology | GKZ |
12/27/2012 | K123526 | ClearRead +Confirm | Riverain Technologies | Radiology | LLZ |
05/17/2012 | K120489 | Tissue of Origin Test Kit FFPE | Pathwork Diagnostics, Inc. | Pathology | OIW |
04/13/2012 | K120161 | AlphaPoint Imaging Software | RadLogics, Inc. | Radiology | LLZ |
12/28/2011 | K111776 | DeltaView Model 2.1 | Riverain Medical Group,Llc | Radiology | LLZ |
09/16/2011 | K102778 | CellaVision® DM1200 with the body fluid application | CellaVision AB | Hematology | JOY |
05/12/2010 | K092116 | EasyCell | Medica Corporation | Hematology | JOY |
12/05/2008 | K080595 | CellaVision DM96 with the body fluid application | Cella Vision AB | Hematology | JOY |
09/12/2008 | K082483 | Quantra | Hologic, Inc. | Radiology | LLZ |
07/30/2008 | K080896 | Pathwork Tissue of Origin Test | Pathwork Diagnostics Inc. | Pathology | OIW |
07/17/2008 | K081140 | Visensia | OBS Medical | Cardiovascular | MHX |
05/15/2008 | K080762 | IB Neuro, Version 1.0 | Imaging Biometrics, LLC | Radiology | LNH |
02/10/2004 | K033840 | CellaVision DM96 Automatic Hematology Analyzer | Cella Vision AB | Hematology | JOY |
03/15/2001 | K003301 | DiffMaster Octavia Automatic Hematology Analyzer | CellaVision AB | Hematology | JOY |
03/11/1997 | K955841 | Compumedics Sleep Monitoring System | Computmedics Sleep Pty. Ltd. | Anesthesiology | MNR |
11/08/1995 | P940029 | PAPNET Testing System | Neuromedical Systems, Inc. | Pathology | MNM |
01/28/2022 | K203260 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | Radiology | QAS |
01/24/2022 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | Radiology | IYN |
01/20/2022 | K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
01/19/2022 | K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | Radiology | QIH |
01/19/2022 | K212012 | Follicle Clarity | Cycle Clarity | Radiology | QIH |
01/14/2022 | K210760 | Precise Image | Philips Medical Systems Nederland, B.V. | Radiology | JAK |
01/14/2022 | K213737 | Quantib ND | Quantib B.V. | Radiology | LLZ |
01/14/2022 | K213307 | Eclipse II with Smart Noise Cancellation | Carestream Health Inc. | Radiology | MQB |
01/12/2022 | K212005 | UNiD Spine Analyzer | MEDICREA International, Inc. | Radiology | LLZ |
01/07/2022 | K211443 | AIBOLIT 3D+ | AIbolit Technologies, LLC | Radiology | LLZ |
01/06/2022 | K213544 | TOMTEC-ARENA | TOMTEC Imaging Systems GmbH | Radiology | QIH |
12/29/2021 | K213776 | LiverSmart | Resonance Health Analysis Services Pty Ltd | Radiology | PCS |
12/22/2021 | K202404 | BoneMRI | MRIguidance B.V | Radiology | QIH |
12/21/2021 | K210670 | BU-CAD | TaiHao Medical Inc. | Radiology | QDQ |
12/21/2021 | K212690 | qXR-BT | Qure.ai Technologies | Radiology | QIH |
12/20/2021 | K213275 | EchoGo Core (2.0) | Ultromics Limited | Radiology | QIH |
12/16/2021 | K212616 | Koios DS | Koios Medical, Inc. | Radiology | POK |
12/16/2021 | K213628 | VBrain | Vysioneer Inc. | Radiology | QKB |
12/15/2021 | K211803 | HealthPPT | Zebra Medical Vision Ltd. | Radiology | QFM |
12/15/2021 | K213155 | RT-Mind-AI | MedMind Technology Co., Ltd. | Radiology | QKB |
12/09/2021 | K212466 | LVivo Seamless V2.0 | DiA Imaging Analysis Ltd | Radiology | QIH |
12/06/2021 | K213096 | Al-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
12/01/2021 | K213305 | Vantage Fortian 1.5T | Canon Medical Systems Corporation | Radiology | LNH |
11/26/2021 | K211541 | MammoScreen 2.0 | Therapixel | Radiology | QDQ |
11/19/2021 | K211326 | EndoScreener | Chengdu Wision Medical Device Co., LTD. | Gastroenterology & Urology | QNP |
11/19/2021 | K210831 | OnQ Neuro | CorTechs Labs, Inc. | Radiology | QIH |
11/17/2021 | K211678 | Lunit INSIGHT MMG | Lunit Inc. | Radiology | QDQ |
11/17/2021 | K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | Radiology | LNH |
11/17/2021 | K212336 | Soteria.AI | Omega Medical Imaging, LLC | Radiology | OWB |
11/16/2021 | K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | Radiology | IYN |
11/15/2021 | K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | Radiology | IYN |
11/10/2021 | K211733 | Lunit INSIGHT CXR Triage | Lunit Inc. | Radiology | QFM |
11/03/2021 | K210543 | IM007 | Implicity, Inc. | Cardiovascular | DQK |
10/29/2021 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | GE Medical Systems, LLC | Radiology | QIH |
10/25/2021 | K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | Elekta Solutions AB | Radiology | QKB |
10/22/2021 | K210807 | FlightPlan for Liver | GE Medical Systems SCS | Radiology | LLZ |
10/22/2021 | K212516 | IRNF App | Apple Inc. | Cardiovascular | QDB |
10/20/2021 | K210632 | Contour ProtegeAI | MIM Software Inc. | Radiology | QKB |
10/14/2021 | K210999 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
10/14/2021 | K212261 | StrokeSENS LVO | Circle Neurovascular Imaging, Inc | Radiology | QAS |
10/12/2021 | K212116 | VBrain-OAR | Vysioneer Inc. | Radiology | QKB |
09/28/2021 | K211964 | SubtlePET | Subtle Medical, Inc. | Radiology | KPS |
09/21/2021 | DEN200080 | Paige Prostate | Paige.AI | Pathology | QPN |
09/17/2021 | K212067 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | Radiology | JAK |
09/17/2021 | K212269 | Intelligent NR | Canon Inc. | Radiology | MQB |
09/15/2021 | K210085 | HealthCCSng | Zebra Medical Vision Ltd. | Radiology | JAK |
09/10/2021 | K211828 | Aquilion Exceed LB | Canon Medical Systems Corporation | Radiology | JAK |
09/10/2021 | K210438 | Versana Premier | GE Medical Systems Ultrasound And Primary Care Diagnostics | Radiology | IYN |
09/09/2021 | K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
09/08/2021 | K203555 | AmCAD-UT | AmCad BioMed Corporation | Radiology | QIH |
09/08/2021 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | Radiology | IYN |
09/08/2021 | K211945 | V8 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | Radiology | IYN |
09/08/2021 | DEN200030 | Feops HEARTguide | Feops NV | Cardiovascular | QQI |
09/02/2021 | K211881 | AI Segmentation Varian | Medical Systems, Inc. | Radiology | MUJ |
08/31/2021 | K201560 | Auto Lung Nodule Detection | Samsung Electronics Co.,Ltd. | Radiology | MYN |
08/31/2021 | K212383 | EndoNaut | Therenva SAS | Radiology | OWB |
08/27/2021 | K203696 | RBknee | Radiobotics ApS | Radiology | LLZ |
08/20/2021 | K211846 | Discovery MI Gen2 | GE Medical Systems, LLC. | Radiology | KPS |
08/16/2021 | K212230 | TruSPECT Radiological Image Processing Station | Spectrum Dynamics Medical Ltd | Radiology | LLZ |
08/12/2021 | K211179 | InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | Radiology | QAS |
08/11/2021 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK |
08/06/2021 | K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | Radiology | KPS |
08/06/2021 | K212100 | Kosmos | EchoNous, Inc. | Radiology | IYN |
07/30/2021 | K211222 | qER-Quant | Qure.ai Technologies | Radiology | QIH |
07/30/2021 | K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA Inc. | Radiology | MUJ |
07/27/2021 | K210791 | Us2.v1 | eko.ai Pte. Ltd. d/b/a Us2.ai | Radiology | QIH |
07/27/2021 | K211655 | aPROMISE | EXINI Diagnostics AB | Radiology | LLZ |
07/27/2021 | K212074 | ClariCT.AI | ClariPi Inc. | Radiology | LLZ |
07/27/2021 | K211279 | Volpara Imaging Software | Volpara Health Technologies Limited | Radiology | LLZ |
07/23/2021 | K211951 | GI Genius | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology & Urology | QNP |
07/20/2021 | K210666 | Chest-CAD | Imagen Technologies, Inc | Radiology | MYN |
07/20/2021 | K210719 | Change Healthcare Anatomical AI | Change Healthcare Canada Company | Radiology | QIH |
07/12/2021 | K211506 | PowerLook Density Assessment Software V4.0 | ICAD Inc. | Radiology | QIH |
07/08/2021 | K211788 | HALO | Nico.Lab B.V. | Radiology | QAS |
07/01/2021 | K210611 | MAGNETOM Free.Max | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
06/29/2021 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (publ) | Radiology | MUJ |
06/16/2021 | K210034 | EnsoSleep | EnsoData, Inc. | Neurology | OLZ |
06/02/2021 | K210404 | Transpara 1.7.0 | ScreenPoint Medical B.V. | Radiology | QDQ |
05/21/2021 | K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | Cardiovascular | DQK |
05/19/2021 | K210187 | Overjet Dental Assist | Overjet, Inc. | Radiology | LLZ |
05/14/2021 | K201034 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
05/13/2021 | K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
04/02/2021 | K202928 | DV.Target | DeepVoxel, Inc. | Radiology | QKB |
03/12/2021 | K202284 | Oncospace | Oncospace, Inc. | Radiology | MUJ |
02/04/2021 | K203582 | QUIBIM Precision Prostate (qp-Prostate) | QUIBIM S.L. | Radiology | LLZ |
01/12/2021 | K203280 | Hepatica V1 (Hepatica V1.0.0) | Perspectum Ltd. | Radiology | LNH |
01/11/2021 | P200003 | Imagio Breast Imaging System | Seno Medical Instruments, Inc. | Radiology | QNK |
01/08/2021 | K203329 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
07/27/2023 | K231195 | Brainomix 360 Triage ICH | Brainomix Limited | Radiology | QAS |
07/26/2023 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | Cardiovascular | QNL |
07/25/2023 | K223473 | ME-APDS™; MAGENTIQ-COLO™ | Magentiq Eye LTD | Gastroenterology/Urology | QNP |
07/25/2023 | K230365 | Sonio Detect | Sonio | Radiology | IYN |
07/25/2023 | K230913 | ANDI | Imeka Solutions, Inc. | Radiology | QIH |
07/24/2023 | K223347 | UltraSight AI Guidance | UltraSight Inc |
Radiology | QJU |
07/21/2023 | K230150 | OptimMRI | RebrAIn, SAS | Radiology | QIH |
07/21/2023 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | Neurology | HAW |
07/21/2023 | K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple Inc. | Cardiovascular | QDB |
07/20/2023 | K230039 | uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | QIH |
07/19/2023 | K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | Radiology | OEB |
07/14/2023 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | Brainlab AG | Radiology | QIH |
07/13/2023 | K223424 | Spine Auto Views | GE Medical Systems SCS | Radiology | JAK |
07/13/2023 | K223426 | ECHELON Synergy MRI system | FUJIFILM Healthcare Corporation | Radiology | LNH |
07/12/2023 | K230823 | AusculThing ACC | AusculThing Oy | Cardiovascular | DQD |
07/10/2023 | K223724 | MOZI TPS | Manteia Technologies Co., Ltd | Radiology | MUJ |
07/07/2023 | K231668 | Spine CAMP™ (1.1) | Medical Metrics, Inc | Radiology | QIH |
07/03/2023 | K222745 | Axial3D Insight | Axial Medical Printing Limited | Radiology | QIH |
06/29/2023 | K230337 | EarliPoint | EarliTec Diagnostics, Inc. | Neurology | QPF |
06/22/2023 | K230497 | Bladder AI (AIBV01) | Exo Inc | Radiology | QIH |
06/20/2023 | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty Ltd. | Radiology | LNH |
06/16/2023 | K223357 | EyeArt v2.2.0 | Eyenuk, Inc | Ophthalmic | PIB |
06/16/2023 | K223646 | IB Lab LAMA | IB Lab Gmbh | Radiology | QIH |
06/16/2023 | K223556 | DeepCatch | MEDICALIP Co., Ltd | Radiology | QIH |
06/13/2023 | K230112 | CAC Software | Imbio, Inc. | Radiology | JAK |
06/06/2023 | K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | FEops NV | Radiology | QIH |
05/30/2023 | K223523 | Sonic DL | GE Medical Systems, LLC | Radiology | LNH |
05/25/2023 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | GE Medical Systems, LLC | Radiology | QBS |
05/25/2023 | K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | Cardiovascular | QFJ |
05/23/2023 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | Neurology | OMB |
05/23/2023 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | Radiology | QDQ |
05/19/2023 | K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - AI, Ltd. | Gastroenterology/Urology | QNP |
05/19/2023 | K212758 | Autoplaque | Cedars-Sinai Medical Center: AIM | Radiology | LLZ |
05/17/2023 | K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | Radiology | MUJ |
05/11/2023 | K223623 | SubtleMR (2.3.x) | Subtle Medical, Inc. | Radiology | LLZ |
05/10/2023 | K220437 | Neurophet AQUA | NEUROPHET, Inc. | Radiology | LLZ |
05/04/2023 | K230082 | Auto Segmentation | GE Medical Systems, LLC | Radiology | QKB |
05/04/2023 | K223771 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | Radiology | IYN |
05/02/2023 | K230977 | SIS System | Surgical Information Sciences, Inc. | Radiology | QIH |
05/02/2023 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co.,Ltd. | Cardiovascular | QDA |
04/27/2023 | K223212 | Precision DL | GE Healthcare | Radiology | KPS |
04/27/2023 | K223734 | ENT EM | Brainlab AG | Ear Nose & Throat | PGW |
04/26/2023 | K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | Radiology | LLZ |
04/26/2023 | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | Cardiovascular | MXD |
04/25/2023 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | Radiology | QIH |
04/25/2023 | K230223 | iCAC Device | Bunkerhill, Inc. | Radiology | JAK |
04/21/2023 | K223501 | ViewFinder Software Version 1.1 | Elaitra Ltd | Radiology | QIH |
04/21/2023 | K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | Radiology | IYN |
04/20/2023 | K223287 | Velacur | Sonic Incytes | Radiology | IYO |
04/20/2023 | K230807 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | Radiology | JAK |
04/19/2023 | K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | Neurology | HAW |
04/19/2023 | K230023 | ART-Plan | Therapanacea SAS | Radiology | QKB |
04/17/2023 | K230772 | Quantib Prostate | Quantib B.V. | Radiology | LLZ |
04/14/2023 | K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | Radiology | QKB |
04/13/2023 | K230264 | Ezra Flash | Ezra AI Inc. | Radiology | LLZ |
04/13/2023 | K213986 | CerebralGo Plus | Yukun (Beijing) Technology Co., Ltd | Radiology | QIH |
04/11/2023 | K223830 | Ultrasound System 2300 | BK Medical Aps | Radiology | IYN |
04/07/2023 | K230575 | Limbus Contour | Limbus AI Inc. | Radiology | LLZ |
04/07/2023 | K230658 | SKOUT® system | Iterative Scopes Inc. | Gastroenterology/Urology | QNP |
04/06/2023 | K222360 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions U.S.A. | Radiology | JAK |
04/06/2023 | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | Radiology | LNH |
04/06/2023 | K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | GE Healthcare Finland Oy | Cardiovascular | MHX |
04/06/2023 | K223774 | Contour ProtégéAI | MIM Software Inc. | Radiology | QKB |
04/05/2023 | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | Cardiovascular | MXD |
04/03/2023 | K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd | Radiology | QAS |
03/31/2023 | K213272 | Formus Hip | Formus Labs, Ltd | Radiology | QIH |
03/29/2023 | K222312 | RayStation 12A | Raysearch Laboratories AB (Publ) | Radiology | MUJ |
03/28/2023 | K222174 | RadioLens v1.0 | Synapsica | Radiology | QIH |
03/28/2023 | K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-AI Pty Ltd | Radiology | QFM |
03/28/2023 | K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-AI Pty Ltd | Radiology | QFM |
03/28/2023 | K223343 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutions USA Inc. | Radiology | LNH |
03/28/2023 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | Radiology | MYN |
03/27/2023 | K222746 | Overjet Caries Assist | Overjet, Inc. | Radiology | MYN |
03/22/2023 | K222036 | MPXA-2000 | Medipixel, Inc. | Radiology | QIH |
03/21/2023 | K223490 | FlightPlan for Embolization | GE Medical Systems SCS | Radiology | LLZ |
03/17/2023 | K223073 | AIio | AIio, Inc. | Gastroenterology/Urology | DRG |
03/17/2023 | K223443 | Viz AAA | Viz.ai, Inc. | Radiology | QFM |
03/17/2023 | K221772 | NeuroRPM | New Touch Digital Inc. | Neurology | GYD |
03/10/2023 | K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
03/09/2023 | K223514 | Spectral Bone Marrow | GE Medical Systems, LLC | Radiology | JAK |
03/09/2023 | K221706 | AccuContour | Manteia Technologies Co., Ltd. | Radiology | QKB |
03/07/2023 | K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | Radiology | JAK |
03/03/2023 | K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | Radiology | JAK |
03/02/2023 | K222176 | BoneView | Gleamer | Radiology | QBS |
03/02/2023 | K222884 | Rapid NCCT Stroke | iSchemaView Inc. | Radiology | QAS |
03/01/2023 | K221680 | Xeleris V Processing and Review System | GE Healthcare | Radiology | LLZ |
02/24/2023 | DEN220063 | Caption Interpretation Automated Ejection Fraction Software | Caption Health, Inc | Radiology | QVD |
02/24/2023 | K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | Radiology | LLZ |
02/23/2023 | K222579 | Belun Sleep System BLS-10 | Belun Technology Company Limited |
Anesthesiology | MNR |
02/23/2023 | K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | Radiology | POK |
02/22/2023 | K230197 | BoneMRI v1.6 | MRIguidance B.V | Radiology | QIH |
02/22/2023 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | Radiology | LNH |
02/17/2023 | DEN210022 | PMD-200 | Medasense Biometrics Ltd. | Anesthesiology | QVE |
02/16/2023 | K222755 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | LNH |
02/16/2023 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK |
02/15/2023 | K222389 | ZEUS System | iRhythm Technologies, Inc. | Cardiovascular | DQK |
02/13/2023 | K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. |
Radiology | IYN |
02/06/2023 | K223296 | Videa Perio Assist | VideaHealth, Inc | Radiology | QIH |
02/02/2023 | K222803 | Oncospace | Oncospace, Inc. | Radiology | MUJ |
02/01/2023 | K223396 | Rapid RV/LV | iSchemaView Inc. | Radiology | QIH |
02/01/2023 | K230020 | BriefCase | Aidoc Medical, Ltd. | Radiology | QFM |
02/01/2023 | K222970 | LVivo IQS | DiA Imaging Analysis Ltd. | Radiology | QIH |
01/27/2023 | K221868 | QOCA image Smart CXR Image Processing System | Quanta Computer Inc. |
Radiology | QFM |
01/23/2023 | K222406 | Clarius AI | Clarius Mobile Health Corp. | Radiology | QIH |
01/21/2023 | K223516 | VX1+ | Volta Medical | Cardiovascular | DQK |
01/18/2023 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging Inc. | Radiology | LLZ |
01/13/2023 | K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | Radiology | LLZ |
01/12/2023 | K222458 | AIBOLIT 3D+ | AIbolit Technologies, LLC | Radiology | LLZ |
12/23/2022 | K214036 | AVIEW | Coreline Soft Co., Ltd. | Radiology | QIH |
12/23/2022 | K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. |
Radiology | LNH |
12/16/2022 | K220928 | Overjet Calculus Assist | Overjet, Inc. | Radiology | MYN |
12/16/2022 | K222275 | Saige-Density | DeepHealth, Inc. | Radiology | QIH |
12/16/2022 | K223268 | BrainInsight | Hyperfine, Inc. | Radiology | QIH |
12/05/2022 | K222692 | BriefCase | Aidoc Medical, Ltd. | Radiology | QFM |
11/22/2022 | K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | Radiology | POK |
11/22/2022 | K221716 | CINA | AVICENNA.AI |
Radiology | QAS |
11/21/2022 | K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | Radiology | QIH |
11/18/2022 | K221330 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
11/16/2022 | K221762 | BoneMRI v1.4 | MRlguidance B.V. | Radiology | QIH |
11/14/2022 | K222428 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
11/10/2022 | K221183 | AEYE-DS | AEYE Health, Inc. |
Ophthalmic | PIB |
11/08/2022 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.AI Co., Ltd. | Radiology | QFM |
10/27/2022 | K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH |
10/25/2022 | K222070 | EndoNaut | Therenva SAS | Radiology | LLZ |
10/21/2022 | K223042 | Viz LVO ContaCT | Viz.Ai, Inc. | Radiology | QAS |
10/20/2022 | K222361 | AI-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
10/18/2022 | K221632 | Spine CAMP™ | Medical Metrics, Inc. | Radiology | QIH |
10/14/2022 | K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc | Radiology | QKB |
10/14/2022 | K213857 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
10/07/2022 | K220709 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
10/06/2022 | K221449 | Genius AI Detection 2.0 | Hologic, Inc. | Radiology | QDQ |
10/05/2022 | K221892 | VISIONAIR | PacificMD Biotech Llc |
Ear Nose & Throat | BXQ |
09/30/2022 | K211611 | QIR Suite | CASIS Cardiac Simulation & Imaging Software | Radiology | QIH |
09/29/2022 | K220080 | CogNet QmTRIAGE | MedCognetics, Inc. | Radiology | QFM |
09/28/2022 | K222329 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
09/27/2022 | K221738 | NS-HGlio | Neosoma Inc. | Radiology | QIH |
09/21/2022 | K221179 | SomnoMetry | Neumetry Medical Inc |
Neurology | OLZ |
09/20/2022 | K213353 | Aorta-CAD | Imagen Technologies, Inc. | Radiology | MYN |
09/12/2022 | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | Radiology | JAK |
09/12/2022 | K221456 | Rapid ICH | iSchemaView Inc. | Radiology | QAS |
09/08/2022 | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.AI Co., Ltd. | Radiology | QFM |
09/07/2022 | K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA Inc. |
Radiology | MUJ |
09/06/2022 | K213960 | LiverMultiScan v5 (LMSv5) | Perspectum |
Radiology | LNH |
09/01/2022 | K221241 | DrAid for Radiology v1 | VinBrain Joint Stock Company |
Radiology | QFM |
08/29/2022 | K221100 | Viz RV/LV | Viz.Ai, Inc. |
Radiology | QIH |
08/26/2022 | K222277 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
08/25/2022 | K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Cardiovascular | MXD |
08/24/2022 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | Radiology | QKB |
08/22/2022 | K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
08/19/2022 | K222172 | MI View&GO | Siemens Medical Solutions USA, Inc. |
Radiology | QIH |
08/12/2022 | K213686 | SKOUT Software | Iterative Scopes Inc | Gastroenterology/Urology | QNP |
08/11/2022 | K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmBh |
Radiology | JAK |
08/08/2022 | K213645 | ClearPoint Maestro Brain Model | ClearPoint Neuro, Inc. | Radiology | QIH |
08/03/2022 | K221347 | Transpara 1.7.2 | ScreenPoint Medical B.V. | Radiology | QKB |
08/03/2022 | K221432 | Customize | 3D-Side SA |
Radiology | QIH |
03/16/2022 | K213779 | Customize | 3D-Side SA |
Radiology | QIH |
09/10/2021 | K203785 | ClariSIGMAM | ClariPI Inc. | Radiology | QIH |
08/02/2021 | K211431 | breastscape v1.0 | Olea Medical |
Radiology | QIH |
06/10/2021 | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
03/12/2021 | K203822 | ProFound AI Software V3.0 | ICAD Inc. | Radiology | QDQ |
03/04/2021 | K203323 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | Radiology | LNH |
03/02/2021 | K203617 | MaxFOV 2 | GE Medical Systems, LLC. | Radiology | JAK |
03/01/2021 | DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye Inc. | Cardiovascular | QNV |
02/26/2021 | K203182 | SubtleMR | Subtle Medical, Inc. | Radiology | LLZ |
01/15/2021 | K202767 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | Radiology | LNH |
11/18/2020 | K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | Radiology | LLZ |
09/29/2020 | K202546 | LVivo Seamless | DiA Imaging Analysis Ltd. | Radiology | QIH |
06/03/2020 | K200974 | QLAB Advanced Quantification Software | Philips Healthcare |
Radiology | QIH |
06/01/2020 | K192601 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | QIH |
01/17/2020 | K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | Cardiovascular | DXH |
10/27/2005 | K043341 | BioPlex 2200 ANA Screen with Medical Decision Support Software for Use with BioPlex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories, Inc. | Immunology | NVI |
*Non-FDA publicly available resources:
- Medical AI Evaluation Database (from “How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals,” Wu, E., et al, Nature Medicine, 27, 582-584 (2021))
- A.I.-based algorithms (The Medical Futurist)
- AI Tools database (STAT) (Excel-22KB)
- Supplementary Appendix to “Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20),” Muehlematter UJ, et al., Lancet Digital Health 2021 https://doi.org/10.1016/S2589-7500(20)30292-2. (PDF-856KB)
Note: The FDA has not verified the information that may appear in these resources.