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  1. Software as a Medical Device (SaMD)

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
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11/04/2019 K190013 WellDoc BlueStar WellDoc, Inc General Hospital MRZ
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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
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*Non-FDA publicly available resources:

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

 
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