U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Digital Health Center of Excellence
  4. Software as a Medical Device (SaMD)
  5. Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
  1. Software as a Medical Device (SaMD)

Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

October 5, 2022 update: 178 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. With this update, the FDA has also added the ability to download the list as an Excel file.

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 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 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
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

*Non-FDA publicly available resources:

Note: The FDA has not verified the information that may appear in these resources.

Back to Top