# AI Device Index: full text of key pages

> Plain-text copies of the main public pages of https://aideviceindex.com/ for AI assistants and search tools. Generated 2026-10-23. Index: https://aideviceindex.com/llms.txt . All pages: https://aideviceindex.com/sitemap.xml

Individual device and company pages are not included here (there are over 1,700); see the sitemap for every URL.

## About · AI Device Index
URL: https://aideviceindex.com/about
Summary: AI Device Index is an independent, documented dataset of every AI-enabled medical device on FDA's list, built for analysts, regulatory teams, investors…

 About
 AI Device Index is an independent, documented dataset of every AI-enabled medical device on FDA's list, built for analysts, regulatory teams, investors and researchers who need clean rows instead of copy-paste.
 Not affiliated with FDA or any device maker. Informational dataset only. Not regulatory, legal or medical advice. Verify against FDA sources before relying on any entry.
 Access and pricing
 Browsing is free. Any paid download or plan needs approval before launch.

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## AI-enabled medical device companies · AI Device Index
URL: https://aideviceindex.com/companies
Summary: Companies with three or more devices on FDA's AI-enabled device list. Names appear as filed with FDA (all-caps filings shown in title case); spelling…

 Devices by company
 Companies with three or more devices on FDA's AI-enabled device list. Names appear as filed with FDA (all-caps filings shown in title case); spelling variants are grouped.
 Siemens Medical Solutions USA, Inc. (67)
 Canon Medical Systems Corporation (42)
 Shanghai United Imaging Healthcare Co., Ltd. (39)
 Aidoc Medical, Ltd. (35)
 GE Medical Systems Ultrasound and Primary Care Diagnostics (31)
 GE Medical Systems, LLC (24)
 Philips Ultrasound LLC (21)
 Samsung Medison Co., Ltd. (18)
 Siemens Healthcare GmbH (15)
 iSchemaView, Inc. (15)
 GE Medical Systems SCS (13)
 Clarius Mobile Health Corp. (12)
 Ever Fortune.AI Co., Ltd. (12)
 Hyperfine, Inc. (12)
 Overjet, Inc. (11)
 Viz.ai, Inc. (11)
 Coreline Soft Co., Ltd. (10)
 DiA Imaging Analysis Ltd. (10)
 Subtle Medical, Inc. (10)
 Brainlab AG (9)
 DeepHealth, Inc. (9)
 Hologic, Inc. (9)
 Philips Medical Systems Nederland B.V. (9)
 Qure.ai Technologies (9)
 Zebra Medical Vision Ltd. (9)
 Brainomix Limited (8)
 BunkerHill Health (8)
 GE Healthcare (8)
 GE Healthcare Japan Corporation (8)
 Pearl Inc. (8)
 Quantib BV (8)
 RaySearch Laboratories AB (publ) (8)
 Avicenna.AI (7)
 Circle Cardiovascular Imaging Inc. (7)
 Esaote, S.p.A. (7)
 Fujifilm Corporation (7)
 HeartFlow, Inc. (7)
 MIM Software Inc. (7)
 Medtronic, Inc. (7)
 Surgical Information Sciences, Inc. (7)
 Therapixel (7)
 Tyto Care , Ltd. (7)
 iCAD Inc. (7)
 AliveCor, Inc. (6)
 Annalise-AI Pty Ltd (6)
 Arterys Inc. (6)
 Cosmo Artificial Intelligence - AI Ltd (6)
 Imagen Technologies, Inc (6)
 Lunit Inc. (6)
 Oxehealth Limited (6)
 ScreenPoint Medical B.V. (6)
 TeraRecon, Inc. (6)
 iRhythm Technologies, Inc. (6)
 AIRS Medical Inc. (5)
 Anumana, Inc. (5)
 Apple Inc. (5)
 BrightHeart (5)
 CellaVision AB (5)
 GE Healthcare (Tianjin) Company Limited (5)
 JLK, Inc. (5)
 Neurophet., Inc. (5)
 Peek Health, S.A. (5)
 Philips Healthcare (Suzhou) Co., Ltd. (5)
 Radformation, Inc. (5)
 Sonio (5)
 Varian Medical Systems, Inc. (5)
 Volta Medical (5)
 Bonraybio Co., LTD. (4)
 BrainScope Company, Inc. (4)
 Butterfly Network, Inc. (4)
 Caption Health (4)
 ClariPi Inc. (4)
 Cleerly, Inc. (4)
 Disior Ltd (4)
 EOS imaging (4)
 EchoNous, Inc. (4)
 Exo Inc (4)
 Healthy.io Ltd. (4)
 Huxley Medical (4)
 ImpediMed Limited (4)
 Iterative Scopes, Inc. (4)
 Magentiq Eye, Ltd. (4)
 Manteia Technologies Co., Ltd. (4)
 Medicalgorithmics S.A. (4)
 Mighty Oak Medical (4)
 Resonance Health Analysis Services Pty Ltd (4)
 Shanghai United Imaging Intelli

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## Contact · AI Device Index
URL: https://aideviceindex.com/contact
Summary: Email support@aideviceindex.com . We read every message and usually reply within a few business days.

 Contact
 Email support@aideviceindex.com . We read every message and usually reply within a few business days.
 Please don't send medical, legal or confidential information by email.

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## Image credits · AI Device Index
URL: https://aideviceindex.com/credits
Summary: Hero and device-grid images are AI-generated illustrations of generic device types, not any specific company's product.

 Image credits
 Patent drawings are reproduced from issued US patents; each was checked for a copyright or mask-work notice (37 CFR 1.71(d)-(e)) and none was found.
 Patent drawings
 HeartFlow Analysis : Patent drawing, US 8,315,812 B2 (HeartFlow, Inc.), via USPTO / Google Patents. Source . US patent drawing; works of the US Government/USPTO publications are not subject to copyright restrictions on reproduction (37 CFR 1.71(d)-(e) notice aside, patent drawings are routinely reproduced as public record). Used unmodified in content, recolored/cropped for layout.
 IDx-DR v2.3 : Patent drawing, US 7,474,775 B2 (University of Iowa Research Foundation (inventors incl. Michael D. Abràmoff)), via USPTO / Google Patents. Source . US patent drawing; works of the US Government/USPTO publications are not subject to copyright restrictions on reproduction (37 CFR 1.71(d)-(e) notice aside, patent drawings are routinely reproduced as public record). Used unmodified in content, recolored/cropped for layout.
 Eko Foundation Analysis Software with Transformers (EFAST) : Patent drawing, US 9,973,847 B2 (Eko Devices, Inc. (now Eko Health, Inc.)), via USPTO / Google Patents. Source . US patent drawing; works of the US Government/USPTO publications are not subject to copyright restrictions on reproduction (37 CFR 1.71(d)-(e) notice aside, patent drawings are routinely reproduced as public record). Used unmodified in content, recolored/cropped for layout.
 Hypertension Notification Feature (HTNF) : Patent drawing, US 11,432,766 B2 (Apple Inc.), via USPTO / Google Patents. Source . US patent drawing; works of the US Government/USPTO publications are not subject to copyright restrictions on reproduction (37 CFR 1.71(d)-(e) notice aside, patent drawings are routinely reproduced as public record). Used unmodified in content, recolored/cropped for layout.
 Drawings show each company's patented technology, not necessarily the cleared device version.
 Illustrations
 Hero and device-grid images are AI-generated illustrations of generic device types, not any specific company's product.

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## Device index · AI Device Index
URL: https://aideviceindex.com/devices
Summary: Search and filter every device in FDA's AI-enabled device list.

 Device index
 Search and filter every device in FDA's AI-enabled device list.
 Live data 1,614 devices from FDA's AI-enabled device list (through 2026-06-29), joined to openFDA. Dataset rebuilt 2026-10-11. Updated weekly.
 Search Panel All 
 Decision Number Device Company Panel Pathway 
 Browse by specialty or by company .
 Showing up to 200 rows; refine the search to narrow down. Full downloadable file: coming soon.
 Dataset license: our compilation is licensed under CC BY 4.0 (credit "AI Device Index, aideviceindex.com"). The underlying FDA and openFDA records are U.S. government works in the public domain.

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## Disclaimer · AI Device Index
URL: https://aideviceindex.com/disclaimer
Summary: © 2026 AI Device Index · Informational dataset only. Not regulatory, legal or medical advice. Verify against FDA sources before relying on any entry.

 Disclaimer
 Informational dataset only. Not regulatory, legal or medical advice. Verify against FDA sources before relying on any entry.

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## AI Device Index · Every FDA-listed AI medical device
URL: https://aideviceindex.com/
Summary: Search all 1,614 FDA-listed AI-enabled medical devices by specialty, company, clearance pathway and date, each linked to its FDA and openFDA record.

>
 Explore: Browse all 1,614 devices · Example device page · How we build it · Updates 
 Recently added to FDA's list The index moves when FDA does.
 Updated weekly. These are the newest decisions in the current dataset (FDA list through Jun 29, 2026; dataset rebuilt Oct 11, 2026).
 Changelog Oct 11, 2026: v1 build · 1,614 devices · 1,614 of 1,614 matched to openFDA · 1,553 510(k), 40 De Novo, 21 PMA/PMA supplement 
 Jun 29, 2026 Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) Agada Medical, Ltd. · K253628 · 510(k) · Radiology 
 Jun 29, 2026 ADAS 3D Adas3D Medical S.L. · K253969 · 510(k) · Radiology 
 Jun 29, 2026 Alturion Series Diagnostic Ultrasound System Philips Ultrasound, LLC · K260667 · 510(k) · Radiology 
 Jun 27, 2026 SOMNUM (SOMNUM) Honeynaps Co., Ltd. · K253390 · 510(k) · Neurology 
 Jun 26, 2026 MammoScreen® (5) Therapixel · K260714 · 510(k) · Radiology 
 Jun 25, 2026 syngo.CT Coronary Cockpit Siemens Medical Solutions USA, Inc. · K253786 · 510(k) · Radiology 
 From the patent record Real devices in the index, as their inventors drew them.
 HeartFlow Analysis · HeartFlow, Inc. · FDA K250902 Patent drawing US 8,315,812 B2, HeartFlow, Inc., via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version. IDx-DR v2.3 · Digital Diagnostics Inc. · FDA K213037 Patent drawing US 7,474,775 B2, University of Iowa Research Foundation (inventors incl. Michael D. Abràmoff), via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version. Eko Foundation Analysis Software with Transformers (EFAST) · Eko Health, Inc. · FDA K251494 Patent drawing US 9,973,847 B2, Eko Devices, Inc. (now Eko Health, Inc.), via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version. Hypertension Notification Feature (HTNF) · Apple Inc. · FDA K250507 Patent drawing US 11,432,766 B2, Apple Inc., via USPTO / Google Patents. Shows the company's patented technology, not necessarily the cleared version. 
 Illustration. Generic device types (ultrasound probe, stethoscope, wearable, retinal camera), not any specific company's product. What's in a row Pathway, review time, product code, class.
 Each FDA entry joined to openFDA so you can sort ultrasound from ECG from retinal imaging in seconds.
 What you get
 01 Joined & checked
 Every device matched to openFDA records; mismatches flagged, not hidden.
 02 Updated weekly
 New FDA decisions land in the index with a pu

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## Methodology · AI Device Index
URL: https://aideviceindex.com/methodology
Summary: Exactly what is in the data, where it comes from and what it can't tell you.

 Methodology
 Exactly what is in the data, where it comes from and what it can't tell you.
 Sources
 FDA's list of AI-enabled medical devices (through 2026-06-29).
 openFDA 510(k), De Novo and PMA records for review time, pathway, product code, class and regulation.
 How we join and check
 Each FDA list entry is matched to its openFDA record by submission number. Current QA: 1,614 of 1,614 joined; 0 duplicates; 2 product-code mismatches and 1 date mismatch logged and flagged, not hidden; 34 text-encoding fixes.
 By pathway
 Pathway Devices 
 510(k) 1,553 
 De Novo 40 
 PMA 17 
 PMA supplement 4 
 Limits
 FDA's list currently runs only through 2026-06-29 and FDA says it is not comprehensive.
 No predicate-device data yet.
 Change-control-plan (PCCP) detection uses device names only, so it undercounts.
 Company names are not normalized.
 Review time is calendar days, not FDA review clock.
 Dataset license: our compilation is licensed under CC BY 4.0 (credit "AI Device Index, aideviceindex.com"). The underlying FDA and openFDA records are U.S. government works in the public domain.

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## Privacy · AI Device Index
URL: https://aideviceindex.com/privacy
Summary: What AI Device Index collects (your email, only if you sign up), who processes it, and how to unsubscribe or delete your data.

 Privacy
 Last updated October 18, 2026.
 AI Device Index (aideviceindex.com) is an independent publication operated by Phillip Alvelda. You can reach us at support@aideviceindex.com .
 What we collect
 Your email address , plus your name if you choose to give it, when you sign up. That's all we ask for. We don't record your IP address with your sign-up.
 Basic server logs. These come from our hosting provider (Cloudflare) for security purposes. We don't run analytics or advertising cookies on this site.
 How we send email
 We store subscriber lists on our own server, using the open-source software Listmonk on a DigitalOcean server in the US. Email is delivered through Amazon Simple Email Service (Amazon SES) , run by Amazon Web Services, Inc. Amazon SES processes your address only to deliver our messages and to handle bounces and spam complaints.
 Email tracking
 Open and click tracking is turned off . Our emails contain no tracking pixels, and the links in them aren't rewritten to track clicks.
 Who processes your data
 Cloudflare hosts the website, protects it from abuse, and routes the sign-up form.
 DigitalOcean hosts our mailing-list server.
 Amazon Web Services (Amazon SES) delivers our email.
 We don't sell, rent or share your email address with advertisers.
 Your choices
 Unsubscribe at any time using the link in every email.
 Ask for a copy of your data, or for it to be deleted, by writing to support@aideviceindex.com . We'll do it within 30 days.
 Signing up is double opt-in. Nothing is sent until you confirm your address.
 Retention
 If you unsubscribe, we keep only your address on a suppression list, so we don't email you again by mistake.
 If you ask us to delete your data, we erase it completely.
 Children
 This site isn't directed at children under 13.
 Contact
 support@aideviceindex.com · 350 Stoneyridge LN, Unit 2, Walnut Creek, CA 94596
 Changes
 If we change this policy, we'll post the update here and note the date.

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## AI-enabled medical devices by specialty · AI Device Index
URL: https://aideviceindex.com/specialties
Summary: FDA-listed AI-enabled medical devices grouped by FDA review panel.

 Devices by specialty
 FDA-listed AI-enabled medical devices grouped by FDA review panel.
 Radiology (1230)
 Cardiovascular (154)
 Neurology (73)
 Anesthesiology (30)
 Gastroenterology-Urology (27)
 Hematology (22)
 Pathology (10)
 Ophthalmic (10)
 General and Plastic Surgery (9)
 Clinical Chemistry (9)
 Orthopedic (8)
 Dental (7)
 Microbiology (7)
 General Hospital (6)
 Obstetrics and Gynecology (5)
 Clinical Toxicology (5)
 Ear Nose & Throat (1)
 Immunology (1)

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## Anesthesiology AI-enabled medical devices (30) · AI Device Index
URL: https://aideviceindex.com/specialty/anesthesiology
Summary: 30 FDA-listed AI-enabled medical devices reviewed by the Anesthesiology panel, newest first.

 Anesthesiology AI-enabled devices
 30 FDA-listed AI-enabled medical devices reviewed by the Anesthesiology panel, newest first.
 Decision Number Device Company Panel 
 2026-06-22 K253148 RX-1 Sleep Vivaquant, Inc. Dba Rhythm Express Anesthesiology 
 2026-06-02 K252844 Tyto Insights for Wheeze Detection (with PCCP) Tyto Care , Ltd. Anesthesiology 
 2026-05-01 K253030 Capnostream™35 Portable Respiratory Monitor (PM35MN) Covidien, LLC Anesthesiology 
 2026-04-27 K252628 CASSIE Wesper, Inc. Anesthesiology 
 2025-12-10 K252497 SANSA HSAT Huxley Medical Anesthesiology 
 2025-12-05 K251657 Personalized Therapy Comfort Settings (PTCS) ResMed Corp Anesthesiology 
 2025-10-29 K250882 SANSA HSAT Huxley Medical Anesthesiology 
 2025-08-15 K250818 Nerveblox Smart Alfa Teknoloji San. Ve Tic. A.S. Anesthesiology 
 2025-04-07 K243567 Tyto Insights for Rhonchi Detection Tyto Care , Ltd. Anesthesiology 
 2025-02-28 K242798 Airmod Heroic Faith International Ltd. Anesthesiology 
 2025-02-03 K243268 TipTraQ (TTQ001) PranaQ Pte. Ltd. Anesthesiology 
 2025-01-28 K244027 SANSA HSAT Huxley Medical Anesthesiology 
 2024-09-13 K240929 Sleep Apnea Notification Feature (SANF) Apple Inc. Anesthesiology 
 2024-07-15 K240285 Huxley SANSA Home Sleep Apnea Test (1000-00) Huxley Medical Anesthesiology 
 2024-07-02 K240555 Tyto Insights for Crackles Detection Tyto Care Ltd. Anesthesiology 
 2024-02-09 K231355 Aurora EnsoData Anesthesiology 
 2024-02-06 DEN230041 Sleep Apnea Feature Samsung Electronics Co., Ltd Anesthesiology 
 2023-12-13 K232237 Tyto Insights for Wheeze Detection Tyto Care Ltd. Anesthesiology 
 2023-10-06 K232787 ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited Anesthesiology 
 2023-03-31 DEN200011 Masimo SafetyNet Masimo Corporation Anesthesiology 
 2023-02-23 K222579 Belun Sleep System BLS-100 Belun Technology Company Limited Anesthesiology 
 2023-02-17 DEN210022 PMD-200 Medasense Biometrics Ltd. Anesthesiology 
 2022-10-18 DEN220024 ScanNav Anatomy Peripheral Nerve Block Intelligent Ultrasound Limited Anesthesiology 
 2022-10-05 K221892 VISIONAIR PacificMD Biotech Llc Anesthesiology 
 2020-01-02 K183089 Air Next NuvoAir AB Anesthesiology 
 2019-02-04 K181916 d-Nav System Hygieia, Inc Anesthesiology 
 2017-05-05 K163665 MATRx plus Zephyr Sleep Technologies Anesthesiology 
 2015-11-05 K150102 SnoreSounds Appian Medical, Inc. Anesthesiology 
 2015-04-24 K142918 EndoTool SubQ Monarch Medical Technologies Anesthesiology 
 1997-03-11 K95

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## Cardiovascular AI-enabled medical devices (154) · AI Device Index
URL: https://aideviceindex.com/specialty/cardiovascular
Summary: 154 FDA-listed AI-enabled medical devices reviewed by the Cardiovascular panel, newest first.

 Cardiovascular AI-enabled devices
 154 FDA-listed AI-enabled medical devices reviewed by the Cardiovascular panel, newest first.
 Decision Number Device Company Panel 
 2026-06-08 K260332 EchoNext Pathwai, Inc. Cardiovascular 
 2026-05-29 K252859 ZEUS Platform (FG0501US) iRhythm Technologies, Inc. Cardiovascular 
 2026-05-22 DEN250057 PCWP Analysis Software Cardiosense, Inc. Cardiovascular 
 2026-04-17 K252945 Novasight Hybrid System Conavi Medical, Inc. Cardiovascular 
 2026-04-07 K253801 ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) Anumana, Inc. Cardiovascular 
 2026-03-28 K252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) Anumana, Inc. Cardiovascular 
 2026-03-12 K252089 Tyto Stethoscope (G3) Tyto Care , Ltd. Cardiovascular 
 2026-02-20 K252972 CARTO™ 3 EP Navigation System V8.4 Biosense Webster, Inc. Cardiovascular 
 2026-02-13 K250233 PreemptiveAI Clinical SDK Measure Labs, Inc. (Dba Preemptiveai, Inc.) Cardiovascular 
 2026-02-06 K252076 Kneevoice Cartilage Evaluation System (750-3600-001) Kneevoice, Inc. Cardiovascular 
 2026-02-06 K251218 SafeBeat Rx App SafeBeat Rx, Inc. Cardiovascular 
 2026-02-02 K251200 Vital Signs Oxehealth Limited Cardiovascular 
 2026-01-23 K243349 BodyGuardian Remote Monitoring System (BGRMS v3.0) Boston Scientific Cardiac Diagnostic Technologies, Inc. Cardiovascular 
 2026-01-22 K252984 Perin Health System (PHD80060-2) Perin Health Devices, LLC Cardiovascular 
 2026-01-09 K252589 Corvair Monza AliveCor, Inc. Cardiovascular 
 2025-12-19 K252284 eMurmur Heart AI Csd Labs Cardiovascular 
 2025-12-18 K253516 Assert-IQ (DM5100) Abbott Medical Cardiovascular 
 2025-12-16 K252204 prolaio eVO2peak Module (Version 1.0) Prolaio, Inc. Cardiovascular 
 2025-12-11 K253141 DeepRhythmAI Medicalgorithmics S.A. Cardiovascular 
 2025-11-25 K250635 FEops HEARTguide Simulation Application Feops NV Cardiovascular 
 2025-11-21 K251293 CardioVision Icardio.Ai Cardiovascular 
 2025-10-28 P220012/S059 Aurora EV ICD (DVEA3E4) Medtronic, Inc. Cardiovascular 
 2025-10-28 P980016/S939 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I Medtronic Cardiac Rhythm Disease Management Cardiovascular 
 2025-09-19 K250649 Bunkerhill ECG-EF BunkerHill Health Cardiovascular 
 2025-09-17 K251221 Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) Abbott Cardiovascular 
 2025-09-12 K251518 Volta AF-Xplorer II Volta Medi

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## Clinical Chemistry AI-enabled medical devices (9) · AI Device Index
URL: https://aideviceindex.com/specialty/clinical-chemistry
Summary: 9 FDA-listed AI-enabled medical devices reviewed by the Clinical Chemistry panel, newest first.

 Clinical Chemistry AI-enabled devices
 9 FDA-listed AI-enabled medical devices reviewed by the Clinical Chemistry panel, newest first.
 Decision Number Device Company Panel 
 2023-09-08 K222921 Minuteful-kidney test Healthy.io Ltd. Clinical Chemistry 
 2023-06-29 DEN200052 KidneyIntelX.dkd Renalytix AI, Inc. Clinical Chemistry 
 2022-07-06 K210069 Minuteful - kidney test Healthy.io Ltd. Clinical Chemistry 
 2019-07-26 K182384 ACR LAB Urine Analysis Test System Healthy.io Ltd Clinical Chemistry 
 2019-07-18 K191370 DreaMed Advisor Pro DreaMed Diabetes Ltd Clinical Chemistry 
 2018-07-18 K173327 DIP/U.S. Urine Analysis Test System Healthy.io Ltd Clinical Chemistry 
 2018-06-12 DEN170043 DreaMed Advisor Pro DreaMed Diabetes, Ltd. Clinical Chemistry 
 2016-11-30 K161834 One Drop Blood Glucose Monitoring System AgaMatrix, Inc. Clinical Chemistry 
 2015-12-21 K150817 Dario Blood Glucose Monitoring System LabStyle Innovations Ltd. Clinical Chemistry 
 All specialties

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## Clinical Toxicology AI-enabled medical devices (5) · AI Device Index
URL: https://aideviceindex.com/specialty/clinical-toxicology
Summary: 5 FDA-listed AI-enabled medical devices reviewed by the Clinical Toxicology panel, newest first.

 Clinical Toxicology AI-enabled devices
 5 FDA-listed AI-enabled medical devices reviewed by the Clinical Toxicology panel, newest first.
 Decision Number Device Company Panel 
 2018-03-15 K173839 Tissue of Origin Test Kit-FFPE Cancer Genetics, Inc. Clinical Toxicology 
 2012-05-17 K120489 TISSUE OF ORIGIN TEST KIT FFPE Pathwork Diagnostics, Inc. Clinical Toxicology 
 2010-06-08 K092967 PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE Pathwork Diagnostics Clinical Toxicology 
 2008-07-30 K080896 PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST Pathwork Diagnostics, Inc. Clinical Toxicology 
 2005-10-27 K043341 BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories, Inc. Clinical Toxicology 
 All specialties

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## Dental AI-enabled medical devices (7) · AI Device Index
URL: https://aideviceindex.com/specialty/dental
Summary: 7 FDA-listed AI-enabled medical devices reviewed by the Dental panel, newest first.

 Dental AI-enabled devices
 7 FDA-listed AI-enabled medical devices reviewed by the Dental panel, newest first.
 Decision Number Device Company Panel 
 2026-05-08 K260419 LingOral Dental Design System Hangzhou ChohoTech Co., Ltd. Dental 
 2026-04-10 K260082 TRIOS Dx (R1) 3Shape TRIOS A/S Dental 
 2024-05-17 DEN230035 DentalMonitoring Dental Monitoring SAS Dental 
 2024-05-16 K233625 RAYDENT SW RAY Co., Ltd. Dental 
 2024-02-21 K232148 X-Guide Surgical Navigation System X-Nav Technologies, LLC Dental 
 2018-08-23 DEN170090 MATRx plus Zephyr Sleep Technologies Dental 
 2018-01-11 K171122 CEREC Ortho Software Dentsply Sirona Dental 
 All specialties

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## Ear Nose & Throat AI-enabled medical devices (1) · AI Device Index
URL: https://aideviceindex.com/specialty/ear-nose-throat
Summary: 1 FDA-listed AI-enabled medical devices reviewed by the Ear Nose & Throat panel, newest first.

 Ear Nose & Throat AI-enabled devices
 1 FDA-listed AI-enabled medical devices reviewed by the Ear Nose & Throat panel, newest first.
 Decision Number Device Company Panel 
 2026-03-17 DEN250014 Tyto Insights for Eardrum Bulging Detection Tyto Care , Ltd. Ear Nose & Throat 
 All specialties

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## Gastroenterology-Urology AI-enabled medical devices (27) · AI Device Index
URL: https://aideviceindex.com/specialty/gastroenterology-urology
Summary: 27 FDA-listed AI-enabled medical devices reviewed by the Gastroenterology-Urology panel, newest first.

 Gastroenterology-Urology AI-enabled devices
 27 FDA-listed AI-enabled medical devices reviewed by the Gastroenterology-Urology panel, newest first.
 Decision Number Device Company Panel 
 2026-06-04 K253984 Instrument Exit Point on Touch Surgery™ Aide Covidien, LLC Gastroenterology-Urology 
 2026-05-29 K261369 GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) Cosmo Artificial Intelligence - Ai, Ltd. Gastroenterology-Urology 
 2026-04-03 K260724 MAGENTIQ-COLO (ME-APDS) Magentiq Eye, Ltd. Gastroenterology-Urology 
 2026-03-12 K250655 Deep Capsule® (Deep Capsule US) Digestaid - Artificial Intelligence Development SA Gastroenterology-Urology 
 2025-12-22 K253664 SKOUT system Iterative Health Gastroenterology-Urology 
 2025-12-05 K252504 Gastric Alimetry Alimetry , Ltd. Gastroenterology-Urology 
 2025-10-03 K252178 MAGENTIQ-COLO (ME-APDS) Magentiq Eye, Ltd. Gastroenterology-Urology 
 2025-09-12 K252586 CADDIE Odin Medical Limited Gastroenterology-Urology 
 2025-06-27 K250984 Maestro System (REF100) Moon Surgical Gastroenterology-Urology 
 2025-06-24 K250268 HyperSnap Surgical System (HSS) Hypervision Surgical Gastroenterology-Urology 
 2025-05-09 K251126 SKOUT system Iterative Health Gastroenterology-Urology 
 2025-01-24 K244023 MAGENTIQ-COLO (ME-APDS) Magentiq Eye LTD Gastroenterology-Urology 
 2024-07-25 K241887 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) Cosmo Artificial Intelligence - AI Ltd Gastroenterology-Urology 
 2024-07-24 K240044 CADDIE Odin Medical Limited Gastroenterology-Urology 
 2024-07-03 K241508 SKOUT® system Iterative Scopes, Inc. Gastroenterology-Urology 
 2024-04-19 K240781 SKOUT® system Iterative Scopes, Inc. Gastroenterology-Urology 
 2024-01-12 K233964 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) Cosmo Artificial Intelligence - AI Ltd Gastroenterology-Urology 
 2023-12-15 K230751 EW10-EC02 Endoscopy Support Program FUJIFILM Corporation Gastroenterology-Urology 
 2023-12-12 DEN230027 NaviCam ProScan Ankon Technologies co., ltd Gastroenterology-Urology 
 2023-07-25 K223473 ME-APDS™; MAGENTIQ-COLO™ Magentiq Eye LTD Gastroenterology-Urology 
 2023-05-19 K231143 GI Genius System 100 and GI Genius System 200 Cosmo Artificial Intelligence - AI Ltd Gastroenterology-Urology 
 2023-04-07 K230658 SKOUT® system Iterative Scopes Inc. Gastroenterology-Urolog

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## General and Plastic Surgery AI-enabled medical devices (9) · AI Device Index
URL: https://aideviceindex.com/specialty/general-and-plastic-surgery
Summary: 9 FDA-listed AI-enabled medical devices reviewed by the General and Plastic Surgery panel, newest first.

 General and Plastic Surgery AI-enabled devices
 9 FDA-listed AI-enabled medical devices reviewed by the General and Plastic Surgery panel, newest first.
 Decision Number Device Company Panel 
 2026-05-21 DEN250028 DeepView AI® System spectralmd, inc. General and Plastic Surgery 
 2026-03-03 P250008 Claire™ OCT System Perimeter Medical Imaging Ai, Inc. General and Plastic Surgery 
 2025-10-10 K251082 HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) Procept Biorobotics General and Plastic Surgery 
 2025-03-14 K242323 Maestro System (REF100) Moon Surgical General and Plastic Surgery 
 2024-08-20 K240200 HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece Procept BioRobotics General and Plastic Surgery 
 2024-01-12 DEN230008 DermaSensor DermaSensor Inc. General and Plastic Surgery 
 2017-06-28 P150046 NEVISENSE SciBase AB General and Plastic Surgery 
 2012-12-27 P110014 DUNE MEDICAL DEVICES MARGINPROBE SYSTEM Dilon Medical Technologies, Ltd. General and Plastic Surgery 
 2011-11-01 P090012 MELAFIND Strata Skin Sciences, Inc. General and Plastic Surgery 
 All specialties

---

## General Hospital AI-enabled medical devices (6) · AI Device Index
URL: https://aideviceindex.com/specialty/general-hospital
Summary: 6 FDA-listed AI-enabled medical devices reviewed by the General Hospital panel, newest first.

 General Hospital AI-enabled devices
 6 FDA-listed AI-enabled medical devices reviewed by the General Hospital panel, newest first.
 Decision Number Device Company Panel 
 2026-04-30 K250680 Bayesian Health Sepsis Flagging Device Bayesian Health, Inc. General Hospital 
 2026-03-16 K252282 SurgiCount+ System Stryker Instruments General Hospital 
 2024-04-02 DEN230036 Sepsis ImmunoScore Prenosis, Inc. General Hospital 
 2024-01-11 K232250 SurgiCount+ System Stryker Instruments General Hospital 
 2019-11-04 K190013 WellDoc BlueStar WellDoc, Inc. General Hospital 
 2016-08-05 K160338 Triton System Gauss Surgical Inc. General Hospital 
 All specialties

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## Hematology AI-enabled medical devices (22) · AI Device Index
URL: https://aideviceindex.com/specialty/hematology
Summary: 22 FDA-listed AI-enabled medical devices reviewed by the Hematology panel, newest first.

 Hematology AI-enabled devices
 22 FDA-listed AI-enabled medical devices reviewed by the Hematology panel, newest first.
 Decision Number Device Company Panel 
 2026-04-09 K252228 Seaman Pro/Seaman Checkcells, Inc. Hematology 
 2026-02-06 K243348 Athelas Home Athelas, Inc. Hematology 
 2025-06-27 K243144 X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs , Ltd. Hematology 
 2025-05-30 K242830 LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer Bonraybio Co., LTD. Hematology 
 2025-05-09 K242388 LensHooke X12 PRO Semen Analysis System Bonraybio Co., LTD. Hematology 
 2024-05-03 K232416 AUTION EYE AI-4510 Urine Particle Analysis System Arkray Inc. Hematology 
 2023-09-19 K221309 AI100 with Shonit SigTuple Technologies Pvt. Ltd. Hematology 
 2022-05-03 K220013 X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs Ltd. Hematology 
 2022-03-22 K200828 Athelas Home Athelas Inc. Hematology 
 2020-10-28 K202089 LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer Bonraybio Co., Ltd. Hematology 
 2020-10-16 K200595 CellaVision DC-1, CellaVision DC-1 PPA CellaVision AB Hematology 
 2020-10-02 K201301 X100 with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs LTD. Hematology 
 2019-11-01 K190898 Sight OLO Sight Diagnostics Ltd. Hematology 
 2018-11-16 K180343 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd. Hematology 
 2018-11-05 K181288 Athelas One Athelas Inc. Hematology 
 2017-08-01 K171315 Advanced RBC Application Cella Vision AB Hematology 
 2013-03-22 K120771 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc. Hematology 
 2011-09-16 K102778 CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CellaVision AB Hematology 
 2010-05-12 K092116 EASYCELL CELL LOCATOR Medica Corp. Hematology 
 2008-12-05 K080595 CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CellaVision AB Hematology 
 2004-02-10 K033840 CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB Hematology 
 2001-03-15 K003301 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB Hematology 
 All specialties

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## Immunology AI-enabled medical devices (1) · AI Device Index
URL: https://aideviceindex.com/specialty/immunology
Summary: 1 FDA-listed AI-enabled medical devices reviewed by the Immunology panel, newest first.

 Immunology AI-enabled devices
 1 FDA-listed AI-enabled medical devices reviewed by the Immunology panel, newest first.
 Decision Number Device Company Panel 
 2017-04-06 DEN160026 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia 23andMe, Inc. Immunology 
 All specialties

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## Microbiology AI-enabled medical devices (7) · AI Device Index
URL: https://aideviceindex.com/specialty/microbiology
Summary: 7 FDA-listed AI-enabled medical devices reviewed by the Microbiology panel, newest first.

 Microbiology AI-enabled devices
 7 FDA-listed AI-enabled medical devices reviewed by the Microbiology panel, newest first.
 Decision Number Device Company Panel 
 2026-01-22 K251511 PhenoMATRIX Copan Wasp Srl Microbiology 
 2025-01-10 K241676 TriVerity Inflammatix, Inc. Microbiology 
 2020-09-15 K192665 Accelerate Pheno System, Accelerate PhenoTest BC Kit Accelerate Diagnostics, Inc. Microbiology 
 2019-05-15 K183648 APAS Independence with Urine Analysis Module Clever Culture Systems AG Microbiology 
 2019-04-22 K182513 FluChip-8G Influenza A+B Assay InDevR, Inc. Microbiology 
 2013-11-21 K130831 MALDI BIOTYPER CA (MBT-CA) SYSTEM Bruker Daltonics, Inc Microbiology 
 2013-08-21 DEN130013 VITEK MS bioMérieux, Inc. Microbiology 
 All specialties

---

## Neurology AI-enabled medical devices (73) · AI Device Index
URL: https://aideviceindex.com/specialty/neurology
Summary: 73 FDA-listed AI-enabled medical devices reviewed by the Neurology panel, newest first.

 Neurology AI-enabled devices
 73 FDA-listed AI-enabled medical devices reviewed by the Neurology panel, newest first.
 Decision Number Device Company Panel 
 2026-06-27 K253390 SOMNUM (SOMNUM) Honeynaps Co., Ltd. Neurology 
 2026-06-03 K260402 MeRT System Wave Neuroscience Neurology 
 2026-04-22 K253256 myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) Otto Bock Healthcare Products GmbH Neurology 
 2026-03-26 K253379 Stealth AXiS Cranial clinical application Medtronic Navigation, Inc. Neurology 
 2026-03-08 K253668 Onera SleepMap (SLEEPMAP) Onera B.V. Neurology 
 2026-03-05 K253442 EarliPoint Assessment Earlitec Diagnostics Neurology 
 2026-02-12 K253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application Medtronic Navigation, Inc. Neurology 
 2026-01-11 K252842 SafeOp 3: Neural Informatix System Alphatec Spine, Inc. Neurology 
 2025-12-08 K251936 Ceribell Delirium Monitor System Ceribell, Inc. Neurology 
 2025-11-21 K251506 Nelli (Version 7.11) Neuro Event Labs OY Neurology 
 2025-11-17 K252330 DeepRESP Nox Medical Ehf Neurology 
 2025-10-03 K251639 xvision Spine system Augmedics, Ltd. Neurology 
 2025-09-29 K252054 SpineAR SNAP (SyncAR Spine) Surgical Theater, Inc. Neurology 
 2025-09-11 K251316 Mazor X System / Mazor X Stealth Edition Mazor Robotics Ltd. Neurology 
 2025-07-01 K250096 Felix NeuroAI System Fasikl Incorporated Neurology 
 2025-06-20 K250877 TMINI Miniature Robotic System THINK Surgical, Inc. Neurology 
 2025-06-19 K250515 EpiMonitor Empatica Srl Neurology 
 2025-05-16 K250086 OTS Hip Ortoma AB Neurology 
 2025-04-11 K243558 Canvas Dx Cognoa, Inc. Neurology 
 2025-04-09 K243743 autoSCORE (V 2.0.0) Holberg EEG AS Neurology 
 2025-03-26 K243891 EarliPoint System EarliTec Diagnostics Neurology 
 2025-03-14 K241960 DeepRESP Nox Medical ehf Neurology 
 2025-03-13 K250255 xvision Spine system Augmedics Ltd. Neurology 
 2025-02-20 K242447 Falcon HST Compumedics Limited Neurology 
 2025-01-24 K243657 ClearPoint System (Software Version 3.0) ClearPoint Neuro, Inc. Neurology 
 2025-01-13 K243950 ARVIS® Shoulder Kico Knee Innovation Company Pty Ltd Neurology 
 2025-01-06 K243481 TMINI Miniature Robotic System THINK Surgical, Inc. Neurology 
 2024-12-27 K242480 FLASH EVD System (10-0002) 7D Surgical ULC Neurology 
 2024-11-26 K241390 NeuroMatch LVIS Corporation Neurology 
 2024-11-22 K242094 Dreem 3S Beacon Biosignals, Inc. Neurology 
 2024-10-17 K240408 REM

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## Obstetrics and Gynecology AI-enabled medical devices (5) · AI Device Index
URL: https://aideviceindex.com/specialty/obstetrics-and-gynecology
Summary: 5 FDA-listed AI-enabled medical devices reviewed by the Obstetrics and Gynecology panel, newest first.

 Obstetrics and Gynecology AI-enabled devices
 5 FDA-listed AI-enabled medical devices reviewed by the Obstetrics and Gynecology panel, newest first.
 Decision Number Device Company Panel 
 2026-05-15 K250781 Embryo Predict Alife Health Obstetrics and Gynecology 
 2025-08-15 K243851 CHLOE BLAST Fairtility Ltd. Obstetrics and Gynecology 
 2025-01-10 K241009 PeriCALM Patterns 3.0 PeriGen, Inc. Obstetrics and Gynecology 
 2019-07-19 K182798 KIDScore D3 Vitrolife A/S Obstetrics and Gynecology 
 2006-03-16 P040028 LUMA CERVICAL IMAGING SYSTEM Spectra Science Obstetrics and Gynecology 
 All specialties

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## Ophthalmic AI-enabled medical devices (10) · AI Device Index
URL: https://aideviceindex.com/specialty/ophthalmic
Summary: 10 FDA-listed AI-enabled medical devices reviewed by the Ophthalmic panel, newest first.

 Ophthalmic AI-enabled devices
 10 FDA-listed AI-enabled medical devices reviewed by the Ophthalmic panel, newest first.
 Decision Number Device Company Panel 
 2025-04-17 K243878 CLARUS (700) Carl Zeiss Meditec, Inc. Ophthalmic 
 2024-05-15 DEN230043 Notal Vision Home Optical Coherence Tomography (OCT) System Notal Vision Inc Ophthalmic 
 2024-04-23 K240058 AEYE-DS AEYE Health Inc. Ophthalmic 
 2023-06-16 K223357 EyeArt v2.2.0 Eyenuk, Inc. Ophthalmic 
 2022-11-10 K221183 AEYE-DS AEYE Health, Inc. Ophthalmic 
 2022-06-17 K213037 IDx-DR v2.3 Digital Diagnostics Inc. Ophthalmic 
 2021-06-10 K203629 IDx-DR Digital Diagnostics Inc. Ophthalmic 
 2020-08-03 K200667 EyeArt Eyenuk, Inc Ophthalmic 
 2019-06-25 K191194 CLARUS Carl Zeiss Meditec, Inc Ophthalmic 
 2018-04-11 DEN180001 IDx-DR IDx, LLC Ophthalmic 
 All specialties

---

## Orthopedic AI-enabled medical devices (8) · AI Device Index
URL: https://aideviceindex.com/specialty/orthopedic
Summary: 8 FDA-listed AI-enabled medical devices reviewed by the Orthopedic panel, newest first.

 Orthopedic AI-enabled devices
 8 FDA-listed AI-enabled medical devices reviewed by the Orthopedic panel, newest first.
 Decision Number Device Company Panel 
 2026-05-07 K253992 Veritas Reverse Total Shoulder System Restor3D Orthopedic 
 2026-02-04 K260104 Signature™ ONE System Orthosoft Inc. (d/b/a) Zimmer CAS Orthopedic 
 2026-01-12 K251558 Precision AI Surgical Planning System (PAI-SPS) Precision AI Pty, Ltd. Orthopedic 
 2025-03-21 K250186 GoLIF! Lumbar Interbody Fusion System GetSet Surgical, SA Orthopedic 
 2025-01-30 K241292 MyShoulder Planner (5.3SSWPL) Medacta International S.A. Orthopedic 
 2025-01-21 K243955 Precision AI Surgical Planning System (PAI-SPS) Precision AI Pty Ltd Orthopedic 
 2024-08-05 K233992 Precision AI Surgical Planning System (PAI-SPS) Precision AI Pty Ltd Orthopedic 
 2023-12-20 K230850 United Orthopedic Knee Patient Specific Instrumentation Enhatch, Inc. Orthopedic 
 All specialties

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## Pathology AI-enabled medical devices (10) · AI Device Index
URL: https://aideviceindex.com/specialty/pathology
Summary: 10 FDA-listed AI-enabled medical devices reviewed by the Pathology panel, newest first.

 Pathology AI-enabled devices
 10 FDA-listed AI-enabled medical devices reviewed by the Pathology panel, newest first.
 Decision Number Device Company Panel 
 2026-05-04 K254115 ArteraAI Breast Artera, Inc. Pathology 
 2025-12-09 K243449 INFINITT DPS Infinitt Healthcare Co., Ltd. Pathology 
 2025-08-29 K250003 GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) Geneseeq Technology Inc. Pathology 
 2025-07-31 DEN240068 ArteraAI Prostate Artera Inc. Pathology 
 2025-01-24 K241232 Galen™ Second Read™ Ibex Medical Analytics Ltd. Pathology 
 2024-01-31 DEN210035 “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” Hologic Inc. Pathology 
 2023-04-28 P210011 xT CDx Tempus Labs, Inc. Pathology 
 2021-09-21 DEN200080 Paige Prostate Paige.AI Pathology 
 1995-11-08 P940029 PAPNET Testing System Neuromedical Systems, Inc. Pathology 
 1995-09-29 P950009 AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM BD Diagnostics Pathology 
 All specialties

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## Radiology AI-enabled medical devices (1230) · AI Device Index
URL: https://aideviceindex.com/specialty/radiology
Summary: 1230 FDA-listed AI-enabled medical devices reviewed by the Radiology panel, newest first.

 Radiology AI-enabled devices
 1230 FDA-listed AI-enabled medical devices reviewed by the Radiology panel, newest first.
 Decision Number Device Company Panel 
 2026-06-29 K253628 Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) Agada Medical, Ltd. Radiology 
 2026-06-29 K253969 ADAS 3D Adas3D Medical S.L. Radiology 
 2026-06-29 K260667 Alturion Series Diagnostic Ultrasound System Philips Ultrasound, LLC Radiology 
 2026-06-26 K260714 MammoScreen® (5) Therapixel Radiology 
 2026-06-25 K253786 syngo.CT Coronary Cockpit Siemens Medical Solutions USA, Inc. Radiology 
 2026-06-24 K253560 Enhanced Boundary for PCCT Ge Medical Systems, LLC Radiology 
 2026-06-22 K260316 CMN Capillary Function with Oncology Virtual Expert Cercare Medical A/S Radiology 
 2026-06-18 K253050 RadOncAI Informai Radiology 
 2026-06-18 K260190 ARTHUR ROPCA ApS Radiology 
 2026-06-18 K260729 Vascular Assist Occlusion Triage (VAOT) (v1.0) GuideAI Health Radiology 
 2026-06-18 K261713 Synapse PACS (7.6.0) FUJIFILM Healthcare Americas Corporation Radiology 
 2026-06-16 K260844 ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Radiology 
 2026-06-15 K253172 MediAI-OA Crescom Co., Ltd. Radiology 
 2026-06-15 K253690 LungMaps Siemens Healthineers AG Radiology 
 2026-06-15 K253825 Saige-Dx DeepHealth, Inc. Radiology 
 2026-06-15 K260300 WatchMate Software Anumana, Inc. Radiology 
 2026-06-12 K260406 Brainomix 360 Hyperdensity Brainomix Limited Radiology 
 2026-06-11 K260322 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical Radiology 
 2026-06-10 K253192 DeepXray Spina Alpha Intelligence Manifolds, Inc. Radiology 
 2026-06-04 K260497 DEEPVESSEL Plaque Keya Medical Technology Co., Ltd. Radiology 
 2026-06-04 K261519 Sonio Suspect Sonio Radiology 
 2026-06-03 K260780 HeartFocus Deski Radiology 
 2026-05-29 K252947 HistoSonics® Planning Tool HistoSonics, Inc. Radiology 
 2026-05-29 K260077 OrthoGrid Hip AI® 4.0 OrthoGrid Systems, Inc. Radiology 
 2026-05-28 K261405 ANDI 2.2 Imeka Solutions, Inc. Radiology 
 2026-05-27 K254075 Synapse Lung Nodule AI Fujifilm Corporation Radiology 
 2026-05-27 K260123 EPIQ Series Diagnostic Ultrasound System Philips Ultrasound, LLC Radiology 
 2026-05-27 K260680 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Phili

---

## FDA AI-enabled medical device statistics · AI Device Index
URL: https://aideviceindex.com/stats
Summary: 1,614 FDA-listed AI-enabled medical devices: 76.2% radiology, 96.2% 510(k), record 2025 with 335 decisions. Tables by pathway, specialty, year and country.

 FDA AI-enabled medical device statistics
 Updated Oct 17, 2026
 Short answer: FDA's AI-enabled medical device list contains 1,614 devices (decisions through Jun 29, 2026). 76.2% were reviewed by the radiology panel, 96.2% were cleared through 510(k), and 2025 was the record year with 335 decisions.
 Every number on this page is computed from our copy of FDA's AI-enabled device list joined to openFDA, and is recalculated each time the data is rebuilt. See the methodology for what the list does and doesn't cover. Data is free to reuse under CC BY 4.0: devices.json .
 By pathway
 Pathway Devices Share Median review (calendar days) 
 510(k) 1,553 96.2% 136 
 De Novo 40 2.5% 288 
 PMA 17 1.1% 355 
 PMA supplement 4 0.2% 118 
 By specialty (review panel)
 Panel Devices Share 
 Radiology 1,230 76.2% 
 Cardiovascular 154 9.5% 
 Neurology 73 4.5% 
 Anesthesiology 30 1.9% 
 Gastroenterology-Urology 27 1.7% 
 Hematology 22 1.4% 
 Pathology 10 0.6% 
 Ophthalmic 10 0.6% 
 General and Plastic Surgery 9 0.6% 
 Clinical Chemistry 9 0.6% 
 Orthopedic 8 0.5% 
 Dental 7 0.4% 
 Microbiology 7 0.4% 
 General Hospital 6 0.4% 
 Obstetrics and Gynecology 5 0.3% 
 Clinical Toxicology 5 0.3% 
 Ear Nose & Throat 1 0.1% 
 Immunology 1 0.1% 
 By decision year
 Year Devices 
 2026 (through Jun 29) 181 
 2025 335 
 2024 235 
 2023 226 
 2022 162 
 2021 129 
 2020 114 
 2019 80 
 2018 65 
 2017 27 
 2016 18 
 2015 6 
 Before 2015 36 
 By applicant country (top 10)
 Country Devices Share 
 United States 738 45.7% 
 Israel 125 7.7% 
 France 96 5.9% 
 China 85 5.3% 
 South Korea 81 5.0% 
 Japan 63 3.9% 
 Canada 59 3.7% 
 United Kingdom 50 3.1% 
 Netherlands 43 2.7% 
 Germany 33 2.0% 
 Source: FDA, Artificial Intelligence-Enabled Medical Devices list, joined to openFDA 510(k), De Novo and PMA records. Review time is in calendar days from openFDA records, not FDA's review clock. FDA notes its list is not comprehensive.
 FAQ
 How many AI medical devices has FDA authorized?
 FDA's AI-enabled medical device list contains 1,614 devices with decisions through Jun 29, 2026. FDA says the list is not a comprehensive resource.
 Which specialty has the most FDA-listed AI devices?
 Radiology, with 1,230 devices (76.2% of the list).
 How long does FDA review take for AI devices?
 The median review time is 136 calendar days for 510(k) clearances and 288 for De Novo grants on the list.

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## Terms · AI Device Index
URL: https://aideviceindex.com/terms
Summary: Content is provided as-is for information. Informational dataset only. Not regulatory, legal or medical advice. Verify against FDA sources before relying…

 Terms
 Last updated October 13, 2026.
 Use of the site
 Content is provided as-is for information. Informational dataset only. Not regulatory, legal or medical advice. Verify against FDA sources before relying on any entry.
 Sources
 Public data (for example FDA, openFDA, the Federal Register, ClinicalTrials.gov and PubMed) belongs to its publishers; we link to the original for every item.
 Changes
 We may update these terms; the date of the latest change will appear here.
 Contact
 support@aideviceindex.com

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## Updates · AI Device Index
URL: https://aideviceindex.com/updates
Summary: The changelog. The index is rebuilt weekly.

 Updates
 The changelog. The index is rebuilt weekly.
 Oct 11, 2026 · v1 build 1,614 devices · 1,614 of 1,614 matched to openFDA · FDA list through 2026-06-29.
 Weekly updates are logged here.

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## Download
- [Full dataset CSV](https://aideviceindex.com/download/fda_ai_enabled_devices.csv) and [JSON](https://aideviceindex.com/download/fda_ai_enabled_devices.json), CC BY 4.0. Cite as: AI Device Index (2026). FDA AI-Enabled Medical Devices, openFDA-joined (rebuilt 2026-10-11). https://aideviceindex.com/devices#download. Source: U.S. FDA.