Skip to content
Roadmap for Healthcare AI

AI-enabled medical devices (FDA)

The US Food and Drug Administration's own list of AI-enabled medical devices authorised for marketing in the United States: 1614 devices. Filter by FDA review panel, year of decision and submission type.

Source: FDA, Artificial Intelligence-Enabled Medical Devices (list). FDA's file dated 4 Sep 2026; last checked 1 Oct 2026 (checked every Monday). Records are shown as FDA publishes them; only the date format is changed, and the submission type is read from the submission number. Each submission number links to the device's record in FDA's database.

1553
Cleared · 510(k)

Cleared through a 510(k): shown to be substantially equivalent to a device already legally on the US market.

40
Granted · De Novo

Granted through De Novo: a new, low-to-moderate-risk device type with no existing equivalent.

21
Approved · PMA

Approved through premarket approval (PMA): FDA's review for the highest-risk devices.

Reading this list

  • “Authorised” covers all three routes. A 510(k) device is cleared, a De Novo request is granted, and only a PMA device is approved.
  • The panel is the FDA review panel that led the decision, not a clinical specialty. For example, the Anesthesiology panel includes sleep-testing and breath-sound devices.
  • Being on this list is not evidence that a device improves patient outcomes. Check the studies behind it.

Showing the newest 50 of 1614 devices. Filters appear once the page has finished loading.

  • Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)29 Jun 2026
    Agada Medical, Ltd.
    Cleared · 510(k)K253628 · FDA recordRadiologyProduct code QIH
  • ADAS 3D29 Jun 2026
    Adas3D Medical S.L.
    Cleared · 510(k)K253969 · FDA recordRadiologyProduct code QIH
  • Alturion Series Diagnostic Ultrasound System29 Jun 2026
    Philips Ultrasound, LLC
    Cleared · 510(k)K260667 · FDA recordRadiologyProduct code IYN
  • SOMNUM (SOMNUM)27 Jun 2026
    Honeynaps Co., Ltd.
    Cleared · 510(k)K253390 · FDA recordNeurologyProduct code OLZ
  • MammoScreen® (5)26 Jun 2026
    Therapixel
    Cleared · 510(k)K260714 · FDA recordRadiologyProduct code QDQ
  • syngo.CT Coronary Cockpit25 Jun 2026
    Siemens Medical Solutions USA, Inc.
    Cleared · 510(k)K253786 · FDA recordRadiologyProduct code QIH
  • Enhanced Boundary for PCCT24 Jun 2026
    Ge Medical Systems, LLC
    Cleared · 510(k)K253560 · FDA recordRadiologyProduct code JAK
  • RX-1 Sleep22 Jun 2026
    Vivaquant, Inc. Dba Rhythm Express
    Cleared · 510(k)K253148 · FDA recordAnesthesiologyProduct code MNR
  • CMN Capillary Function with Oncology Virtual Expert22 Jun 2026
    Cercare Medical A/S
    Cleared · 510(k)K260316 · FDA recordRadiologyProduct code QIH
  • RadOncAI18 Jun 2026
    Informai
    Cleared · 510(k)K253050 · FDA recordRadiologyProduct code MUJ
  • ARTHUR18 Jun 2026
    ROPCA ApS
    Cleared · 510(k)K260190 · FDA recordRadiologyProduct code IYO
  • Vascular Assist Occlusion Triage (VAOT) (v1.0)18 Jun 2026
    GuideAI Health
    Cleared · 510(k)K260729 · FDA recordRadiologyProduct code QAS
  • Synapse PACS (7.6.0)18 Jun 2026
    FUJIFILM Healthcare Americas Corporation
    Cleared · 510(k)K261713 · FDA recordRadiologyProduct code QIH
  • ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System16 Jun 2026
    Siemens Medical Solutions USA, Inc.
    Cleared · 510(k)K260844 · FDA recordRadiologyProduct code IYN
  • MediAI-OA15 Jun 2026
    Crescom Co., Ltd.
    Cleared · 510(k)K253172 · FDA recordRadiologyProduct code QIH
  • LungMaps15 Jun 2026
    Siemens Healthineers AG
    Cleared · 510(k)K253690 · FDA recordRadiologyProduct code QIH
  • Saige-Dx15 Jun 2026
    DeepHealth, Inc.
    Cleared · 510(k)K253825 · FDA recordRadiologyProduct code QDQ
  • WatchMate Software15 Jun 2026
    Anumana, Inc.
    Cleared · 510(k)K260300 · FDA recordRadiologyProduct code QIH
  • Brainomix 360 Hyperdensity12 Jun 2026
    Brainomix Limited
    Cleared · 510(k)K260406 · FDA recordRadiologyProduct code QIH
  • Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)11 Jun 2026
    Mighty Oak Medical
    Cleared · 510(k)K260322 · FDA recordRadiologyProduct code QIH
  • DeepXray Spina10 Jun 2026
    Alpha Intelligence Manifolds, Inc.
    Cleared · 510(k)K253192 · FDA recordRadiologyProduct code SAO
  • EchoNext8 Jun 2026
    Pathwai, Inc.
    Cleared · 510(k)K260332 · FDA recordCardiovascularProduct code QXO
  • Instrument Exit Point on Touch Surgery™ Aide4 Jun 2026
    Covidien, LLC
    Cleared · 510(k)K253984 · FDA recordGastroenterology-UrologyProduct code SFE
  • DEEPVESSEL Plaque4 Jun 2026
    Keya Medical Technology Co., Ltd.
    Cleared · 510(k)K260497 · FDA recordRadiologyProduct code QIH
  • Sonio Suspect4 Jun 2026
    Sonio
    Cleared · 510(k)K261519 · FDA recordRadiologyProduct code POK
  • MeRT System3 Jun 2026
    Wave Neuroscience
    Cleared · 510(k)K260402 · FDA recordNeurologyProduct code SIG
  • HeartFocus3 Jun 2026
    Deski
    Cleared · 510(k)K260780 · FDA recordRadiologyProduct code QJU
  • Tyto Insights for Wheeze Detection (with PCCP)2 Jun 2026
    Tyto Care , Ltd.
    Cleared · 510(k)K252844 · FDA recordAnesthesiologyProduct code PHZ
  • ZEUS Platform (FG0501US)29 May 2026
    iRhythm Technologies, Inc.
    Cleared · 510(k)K252859 · FDA recordCardiovascularProduct code DQK
  • HistoSonics® Planning Tool29 May 2026
    HistoSonics, Inc.
    Cleared · 510(k)K252947 · FDA recordRadiologyProduct code QTZ
  • OrthoGrid Hip AI® 4.029 May 2026
    OrthoGrid Systems, Inc.
    Cleared · 510(k)K260077 · FDA recordRadiologyProduct code QIH
  • GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)29 May 2026
    Cosmo Artificial Intelligence - Ai, Ltd.
    Cleared · 510(k)K261369 · FDA recordGastroenterology-UrologyProduct code QNP
  • ANDI 2.228 May 2026
    Imeka Solutions, Inc.
    Cleared · 510(k)K261405 · FDA recordRadiologyProduct code QIH
  • Synapse Lung Nodule AI27 May 2026
    Fujifilm Corporation
    Cleared · 510(k)K254075 · FDA recordRadiologyProduct code OEB
  • EPIQ Series Diagnostic Ultrasound System27 May 2026
    Philips Ultrasound, LLC
    Cleared · 510(k)K260123 · FDA recordRadiologyProduct code IYN
  • EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems27 May 2026
    Philips Ultrasound, LLC
    Cleared · 510(k)K260680 · FDA recordRadiologyProduct code IYN
  • PCWP Analysis Software22 May 2026
    Cardiosense, Inc.
    Granted · De NovoDEN250057 · FDA recordCardiovascularProduct code SIF
  • uMR Astra22 May 2026
    Shanghai United Imaging Healthcare Co., Ltd.
    Cleared · 510(k)K260113 · FDA recordRadiologyProduct code LNH
  • Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning22 May 2026
    Canon Medical Informatics, Inc.
    Cleared · 510(k)K260324 · FDA recordRadiologyProduct code QIH
  • DeepView AI® System21 May 2026
    spectralmd, inc.
    Granted · De NovoDEN250028 · FDA recordGeneral and Plastic SurgeryProduct code SHY
  • uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite21 May 2026
    Wuhan United Imaging Healthcare Co.,Ltd
    Cleared · 510(k)K253720 · FDA recordRadiologyProduct code IYN
  • BAC21 May 2026
    DeepHealth, Inc.
    Cleared · 510(k)K254131 · FDA recordRadiologyProduct code QIH
  • MSK Go21 May 2026
    Smart Alfa Teknoloji San. Ve Tic. A.S.
    Cleared · 510(k)K260234 · FDA recordRadiologyProduct code QIH
  • Aquilion ONE (TSX-308A/TSX-306A) V2.020 May 2026
    Canon Medical Systems Corporation
    Cleared · 510(k)K253596 · FDA recordRadiologyProduct code JAK
  • Embryo Predict15 May 2026
    Alife Health
    Cleared · 510(k)K250781 · FDA recordObstetrics and GynecologyProduct code PBH
  • Neurophet SCALE PET15 May 2026
    Neurophet., Inc.
    Cleared · 510(k)K252563 · FDA recordRadiologyProduct code QIH
  • 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 Super15 May 2026
    Wuhan United Imaging Healthcare Co.,Ltd
    Cleared · 510(k)K253716 · FDA recordRadiologyProduct code IYN
  • SubtleHD-CT (1.x)15 May 2026
    Subtle Medical, Inc.
    Cleared · 510(k)K254120 · FDA recordRadiologyProduct code QIH
  • Neurophet AQUA15 May 2026
    Neurophet., Inc.
    Cleared · 510(k)K261273 · FDA recordRadiologyProduct code QIH
  • UNiD™ Spine Analyzer (SW3002)15 May 2026
    Medicrea International S.A.S. (Medtronic)
    Cleared · 510(k)K261289 · FDA recordRadiologyProduct code QIH

Something wrong or missing? Report a problem · See also Track 4: Regulation and governance.