FDA AI-enabled medical devices, by country
All 1,614 AI-enabled devices on the US FDA's list, matched to the applicant's country. 53% come from companies outside the US.
1,614Devices on the list
335Cleared in 2025 (+43% on 2024)
35Countries of applicants
76%Radiology
Devices cleared per year
2026 runs to 29 Jun 2026, the latest decision on the list (published 4 Sep 2026).
Show data table
| Year | Devices |
|---|---|
| 1995 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 5 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 6 |
| 2015 | 6 |
| 2016 | 18 |
| 2017 | 27 |
| 2018 | 65 |
| 2019 | 80 |
| 2020 | 114 |
| 2021 | 129 |
| 2022 | 162 |
| 2023 | 226 |
| 2024 | 235 |
| 2025 | 335 |
| 2026 | 181 |
Where the companies are
Applicant country from FDA 510(k) and PMA records
Show data table
| Country | Devices |
|---|---|
| United States (federal) | 756 |
| Israel | 125 |
| France | 96 |
| China | 85 |
| South Korea | 81 |
| Japan | 63 |
| Canada | 60 |
| United Kingdom | 50 |
| Netherlands | 43 |
| Germany | 33 |
| Taiwan | 30 |
| Australia | 27 |
| Sweden | 25 |
| Belgium | 14 |
| Italy | 13 |
| India | 13 |
| Finland | 12 |
| Spain | 10 |
| Austria | 10 |
| Singapore | 9 |
| Portugal | 8 |
| Denmark | 7 |
| Ireland | 7 |
| Switzerland | 6 |
| Poland | 5 |
| New Zealand | 5 |
| Bulgaria | 4 |
| Norway | 3 |
| Vietnam | 3 |
| Türkiye | 2 |
| Lithuania | 2 |
| Iceland | 2 |
| Virgin Islands, British | 1 |
| Slovenia | 1 |
| Cayman Islands | 1 |
Companies with the most AI devices
Counted per legal entity
By medical specialty
Lead review panel
Search the devices
Newest first
| Device | Company | Country | Specialty | Decision |
|---|---|---|---|---|
| Alturion Series Diagnostic Ultrasound System K260667 | Philips Ultrasound, LLC | United States (federal) | Radiology | 29 Jun 2026 |
| ADAS 3D K253969 | Adas3D Medical S.L. | Spain | Radiology | 29 Jun 2026 |
| Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) K253628 | Agada Medical, Ltd. | Israel | Radiology | 29 Jun 2026 |
| SOMNUM (SOMNUM) K253390 | Honeynaps Co., Ltd. | South Korea | Neurology | 27 Jun 2026 |
| MammoScreen® (5) K260714 | Therapixel | France | Radiology | 26 Jun 2026 |
| syngo.CT Coronary Cockpit K253786 | Siemens Medical Solutions USA, Inc. | United States (federal) | Radiology | 25 Jun 2026 |
| Enhanced Boundary for PCCT K253560 | Ge Medical Systems, LLC | United States (federal) | Radiology | 24 Jun 2026 |
| CMN Capillary Function with Oncology Virtual Expert K260316 | Cercare Medical A/S | Denmark | Radiology | 22 Jun 2026 |
| RX-1 Sleep K253148 | Vivaquant, Inc. Dba Rhythm Express | United States (federal) | Anesthesiology | 22 Jun 2026 |
| Synapse PACS (7.6.0) K261713 | FUJIFILM Healthcare Americas Corporation | United States (federal) | Radiology | 18 Jun 2026 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) K260729 | GuideAI Health | United States (federal) | Radiology | 18 Jun 2026 |
| ARTHUR K260190 | ROPCA ApS | Denmark | Radiology | 18 Jun 2026 |
| RadOncAI K253050 | Informai | United States (federal) | Radiology | 18 Jun 2026 |
| ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System K260844 | Siemens Medical Solutions USA, Inc. | United States (federal) | Radiology | 16 Jun 2026 |
| WatchMate Software K260300 | Anumana, Inc. | United States (federal) | Radiology | 15 Jun 2026 |
| Saige-Dx K253825 | DeepHealth, Inc. | United States (federal) | Radiology | 15 Jun 2026 |
| LungMaps K253690 | Siemens Healthineers AG | Germany | Radiology | 15 Jun 2026 |
| MediAI-OA K253172 | Crescom Co., Ltd. | South Korea | Radiology | 15 Jun 2026 |
| Brainomix 360 Hyperdensity K260406 | Brainomix Limited | United Kingdom | Radiology | 12 Jun 2026 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K260322 | Mighty Oak Medical | United States (federal) | Radiology | 11 Jun 2026 |
| DeepXray Spina K253192 | Alpha Intelligence Manifolds, Inc. | Taiwan | Radiology | 10 Jun 2026 |
| EchoNext K260332 | Pathwai, Inc. | United States (federal) | Cardiovascular | 8 Jun 2026 |
| Sonio Suspect K261519 | Sonio | France | Radiology | 4 Jun 2026 |
| DEEPVESSEL Plaque K260497 | Keya Medical Technology Co., Ltd. | China | Radiology | 4 Jun 2026 |
| Instrument Exit Point on Touch Surgery™ Aide K253984 | Covidien, LLC | United States (federal) | Gastroenterology-Urology | 4 Jun 2026 |
| HeartFocus K260780 | Deski | France | Radiology | 3 Jun 2026 |
| MeRT System K260402 | Wave Neuroscience | United States (federal) | Neurology | 3 Jun 2026 |
| Tyto Insights for Wheeze Detection (with PCCP) K252844 | Tyto Care , Ltd. | Israel | Anesthesiology | 2 Jun 2026 |
| GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) K261369 | Cosmo Artificial Intelligence - Ai, Ltd. | Ireland | Gastroenterology-Urology | 29 May 2026 |
| OrthoGrid Hip AI® 4.0 K260077 | OrthoGrid Systems, Inc. | United States (federal) | Radiology | 29 May 2026 |
| HistoSonics® Planning Tool K252947 | HistoSonics, Inc. | United States (federal) | Radiology | 29 May 2026 |
| ZEUS Platform (FG0501US) K252859 | iRhythm Technologies, Inc. | United States (federal) | Cardiovascular | 29 May 2026 |
| ANDI 2.2 K261405 | Imeka Solutions, Inc. | Canada | Radiology | 28 May 2026 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems K260680 | Philips Ultrasound, LLC | United States (federal) | Radiology | 27 May 2026 |
| EPIQ Series Diagnostic Ultrasound System K260123 | Philips Ultrasound, LLC | United States (federal) | Radiology | 27 May 2026 |
| Synapse Lung Nodule AI K254075 | Fujifilm Corporation | Japan | Radiology | 27 May 2026 |
| Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning K260324 | Canon Medical Informatics, Inc. | United States (federal) | Radiology | 22 May 2026 |
| uMR Astra K260113 | Shanghai United Imaging Healthcare Co., Ltd. | China | Radiology | 22 May 2026 |
| PCWP Analysis Software DEN250057 | Cardiosense, Inc. | United States (federal) | Cardiovascular | 22 May 2026 |
| MSK Go K260234 | Smart Alfa Teknoloji San. Ve Tic. A.S. | Türkiye | Radiology | 21 May 2026 |
| BAC K254131 | DeepHealth, Inc. | United States (federal) | Radiology | 21 May 2026 |
| uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite K253720 | Wuhan United Imaging Healthcare Co.,Ltd | China | Radiology | 21 May 2026 |
| DeepView AI® System DEN250028 | spectralmd, inc. | United States (federal) | General and Plastic Surgery | 21 May 2026 |
| Aquilion ONE (TSX-308A/TSX-306A) V2.0 K253596 | Canon Medical Systems Corporation | Japan | Radiology | 20 May 2026 |
| UNiD™ Spine Analyzer (SW3002) K261289 | Medicrea International S.A.S. (Medtronic) | France | Radiology | 15 May 2026 |
| Neurophet AQUA K261273 | Neurophet., Inc. | South Korea | Radiology | 15 May 2026 |
| SubtleHD-CT (1.x) K254120 | Subtle Medical, Inc. | United States (federal) | Radiology | 15 May 2026 |
| uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super K253716 | Wuhan United Imaging Healthcare Co.,Ltd | China | Radiology | 15 May 2026 |
| Neurophet SCALE PET K252563 | Neurophet., Inc. | South Korea | Radiology | 15 May 2026 |
| Embryo Predict K250781 | Alife Health | United States (federal) | Obstetrics and Gynecology | 15 May 2026 |
| BriefCase-Triage K261317 | Aidoc Medical , Ltd. | Israel | Radiology | 14 May 2026 |
| SubtleHD-PET (1.x) K254013 | Subtle Medical, Inc. | United States (federal) | Radiology | 14 May 2026 |
| Morph K260032 | BeauBrain Healthcare, Inc. | South Korea | Radiology | 13 May 2026 |
| Rayvolve K260378 | AZmed | France | Radiology | 12 May 2026 |
| Velmeni for Dentists (V4D) Endo-Perio K252953 | Velmeni, Inc. | United States (federal) | Radiology | 11 May 2026 |
| LingOral Dental Design System K260419 | Hangzhou ChohoTech Co., Ltd. | China | Dental | 8 May 2026 |
| Veritas Reverse Total Shoulder System K253992 | Restor3D | United States (federal) | Orthopedic | 7 May 2026 |
| Lumify Diagnostic Ultrasound System K252558 | Philips Ultrasound, LLC | United States (federal) | Radiology | 5 May 2026 |
| ArteraAI Breast K254115 | Artera, Inc. | United States (federal) | Pathology | 4 May 2026 |
| MammoSightAI K252954 | Neurocareai, Inc. (Dba Savelife.Ai) | United States (federal) | Radiology | 4 May 2026 |