Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
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 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.
Interest in medical devices incorporating ML functionality has increased in recent years. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510(k) clearance, granted De Novo request, or approved PMA) with ML across many different fields of medicine—and expects this trend to continue.
The FDA is providing this initial list 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.
Contents of this list: This initial list contains publicly available information on AI/ML-enabled devices. The FDA assembled this list by searching FDA’s publicly-facing information, as well as by reviewing 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 AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information.
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
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 |
---|---|---|---|---|---|
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 |
06/11/2021 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Cardiovascular | MXD |
06/10/2021 | K203629 | IDx-DR | Digital Diagnostics Inc. | Ophthalmic | PIB |
06/02/2021 | DEN200069 | Cognoa Asd Diagnosis Aid | Cognoa, Inc. | Neurology | QPF |
05/19/2021 | K210237 | CINA CHEST | Avicenna.AI | Radiology | QAS |
04/30/2021 | K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | KPS |
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 |
04/21/2021 | 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 |
04/14/2021 | 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 |
04/02/2021 | K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | Radiology | MQB |
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 | Aquilion ONE (TSX‐306A/3) V10.4 with Spectral Imaging System | Canon Medical Systems Corporation | Radiology | JAK |
03/23/2021 | K210209 | Viz ICH | Viz.Ai, Inc. | Radiology | QAS |
03/19/2021 | K203235 | VBrain | Vysioneer Inc. | Radiology | QKB |
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 |
03/01/2021 | 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 |
02/19/2021 | K202212 | Truplan | Circle Cardiovascular Imaging Inc. | Radiology | LLZ |
02/09/2021 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | Radiology | LLZ |
02/05/2021 | K210053 | LVivo Software Application | DiA Imaging Analysis Ltd. | Radiology | QIH |
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 |
11/18/2020 | 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 |
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 |
12/11/2019 | 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 |
07/05/19 | 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 |
04/17/2019 | 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 |
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 |
11/02/2018 | 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 |
08/09/2016 | 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 |
01/07/2016 | 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 |
07/17/2008 | 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 |
*Non-FDA publicly available resources:
- Medical AI Evaluation Database (Nature.com)
- A.I.-based algorithms (The Medical Futurist)
- AI Algorithms (American College of Radiology)
- STAT Database: AI Tools (Excel-22KB)
- Supplementary Appendix to Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (PDF-856KB)
Note: The FDA has not verified the information that may appear in these resources.