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Data · FDA AI-Enabled Devices · Decisions through June 29, 2026

How many AI medical devices has the FDA authorized?

FDA lists 1,614 AI-enabled medical devices authorized for marketing in the US, through decisions of June 29, 2026. Radiology accounts for 1,230 of them (76%). FDA authorized 335 in 2025 and 181 so far in 2026, against 173 by the same date in 2025. Source: US Food and Drug Administration, Artificial Intelligence-Enabled Medical Devices list.

AI-enabled devices on FDA's list1,614decisions from 1995 to June 29, 2026
Authorized in 2025335181 so far in 2026
Radiology share76%1,230 devices; cardiovascular is next with 154

Devices authorized per year

Year of FDA's final decision
2017
27
2018
65
2019
80
2020
114
2021
129
2022
162
2023
226
2024
235
2025
335
2026 (to date)
181

By lead review panel

All 1,614 devices
Radiology
1,230
Cardiovascular
154
Neurology
73
Anesthesiology
30
Gastroenterology-Urology
27
Hematology
22
Pathology
10
Ophthalmic
10

What it means

Clinical AI is mostly imaging, and mostly cleared against devices already on the market

1,553 of the 1,614 devices (96%) reached market through 510(k) clearance, which compares a device to one already sold. For a health system, that means the AI question is less "is it allowed" and more "does it fit our workflow, our PACS and our governance process." Imaging departments have the most choice and the most vendor calls.

Companies with the most devices
CompanyDevices
Siemens Medical Solutions USA68
Canon Medical Systems42
Aidoc Medical35
Shanghai United Imaging Healthcare33
Philips Ultrasound24
GE Medical Systems Ultrasound and Primary Care Diagnostics22
GE Medical Systems20
iSchemaView15
Siemens Healthcare13
Samsung Medison13
Clarius Mobile Health12
Hyperfine12

Newest 400 devices

DecisionDeviceCompanyPanel
June 29, 2026Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd.Radiology
June 29, 2026ADAS 3DAdas3D Medical S.L.Radiology
June 29, 2026Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiology
June 27, 2026SOMNUM (SOMNUM)Honeynaps Co., Ltd.Neurology
June 26, 2026MammoScreen® (5)TherapixelRadiology
June 25, 2026syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.Radiology
June 24, 2026Enhanced Boundary for PCCTGe Medical Systems, LLCRadiology
June 22, 2026RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressAnesthesiology
June 22, 2026CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/SRadiology
June 18, 2026RadOncAIInformaiRadiology
June 18, 2026ARTHURROPCA ApSRadiology
June 18, 2026Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthRadiology
June 18, 2026Synapse PACS (7.6.0)FUJIFILM Healthcare Americas CorporationRadiology
June 16, 2026ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Radiology
June 15, 2026MediAI-OACrescom Co., Ltd.Radiology
June 15, 2026LungMapsSiemens Healthineers AGRadiology
June 15, 2026Saige-DxDeepHealth, Inc.Radiology
June 15, 2026WatchMate SoftwareAnumana, Inc.Radiology
June 12, 2026Brainomix 360 HyperdensityBrainomix LimitedRadiology
June 11, 2026Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak MedicalRadiology
June 10, 2026DeepXray SpinaAlpha Intelligence Manifolds, Inc.Radiology
June 8, 2026EchoNextPathwai, Inc.Cardiovascular
June 4, 2026Instrument Exit Point on Touch Surgery™ AideCovidien, LLCGastroenterology-Urology
June 4, 2026DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.Radiology
June 4, 2026Sonio SuspectSonioRadiology
June 3, 2026MeRT SystemWave NeuroscienceNeurology
June 3, 2026HeartFocusDeskiRadiology
June 2, 2026Tyto Insights for Wheeze Detection (with PCCP)Tyto Care , Ltd.Anesthesiology
May 29, 2026ZEUS Platform (FG0501US)iRhythm Technologies, Inc.Cardiovascular
May 29, 2026HistoSonics® Planning ToolHistoSonics, Inc.Radiology
May 29, 2026OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.Radiology
May 29, 2026GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.Gastroenterology-Urology
May 28, 2026ANDI 2.2Imeka Solutions, Inc.Radiology
May 27, 2026Synapse Lung Nodule AIFujifilm CorporationRadiology
May 27, 2026EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiology
May 27, 2026EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLCRadiology
May 22, 2026PCWP Analysis SoftwareCardiosense, Inc.Cardiovascular
May 22, 2026uMR AstraShanghai United Imaging Healthcare Co., Ltd.Radiology
May 22, 2026Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc.Radiology
May 21, 2026uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteWuhan United Imaging Healthcare Co.,LtdRadiology
May 21, 2026BACDeepHealth, Inc.Radiology
May 21, 2026MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.Radiology
May 21, 2026DeepView AI® Systemspectralmd, inc.General and Plastic Surgery
May 20, 2026Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationRadiology
May 15, 2026Embryo PredictAlife HealthObstetrics and Gynecology
May 15, 2026Neurophet SCALE PETNeurophet., Inc.Radiology
May 15, 2026uSONIQUE 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 SuperWuhan United Imaging Healthcare Co.,LtdRadiology
May 15, 2026SubtleHD-CT (1.x)Subtle Medical, Inc.Radiology
May 15, 2026Neurophet AQUANeurophet., Inc.Radiology
May 15, 2026UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)Radiology
May 14, 2026SubtleHD-PET (1.x)Subtle Medical, Inc.Radiology
May 14, 2026BriefCase-TriageAidoc Medical , Ltd.Radiology
May 13, 2026MorphBeauBrain Healthcare, Inc.Radiology
May 12, 2026RayvolveAZmedRadiology
May 11, 2026Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.Radiology
May 8, 2026LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.Dental
May 7, 2026Veritas Reverse Total Shoulder SystemRestor3DOrthopedic
May 5, 2026Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiology
May 4, 2026MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)Radiology
May 4, 2026ArteraAI BreastArtera, Inc.Pathology
May 1, 2026Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCAnesthesiology
April 30, 2026Bayesian Health Sepsis Flagging DeviceBayesian Health, Inc.General Hospital
April 30, 2026Intelligent NRCanon, Inc.Radiology
April 30, 2026Synapse 3D Base Tools (V7.2)Fujifilm CorporationRadiology
April 29, 2026DeepHealth ProstateAIQuantib B.V.Radiology
April 29, 2026syngo Application SoftwareSiemens Medical Solutions USA, Inc.Radiology
April 27, 2026CASSIEWesper, Inc.Anesthesiology
April 24, 2026OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALRadiology
April 23, 2026Lunit INSIGHT MMG (v1.1.10)Lunit, Inc.Radiology
April 23, 2026DS Core CBCT AnatomyDentsply SironaRadiology
April 22, 2026uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.Radiology
April 22, 2026EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.Radiology
April 22, 2026myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)Otto Bock Healthcare Products GmbHNeurology
April 20, 2026FolliscanMim FertilityRadiology
April 17, 2026EdgeFlow UW20Edgecare, Inc.Radiology
April 17, 2026Novasight Hybrid SystemConavi Medical, Inc.Cardiovascular
April 14, 2026Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLCRadiology
April 10, 2026DeepBT Detector-PlusAitewan Biomedical Technology, Inc.Radiology
April 10, 2026AI-Rad Companion Organs RTSiemens Healthcare GmbHRadiology
April 10, 2026Relu CloudRelu BVRadiology
April 10, 2026syngo Dynamics (VA41F)Siemens Healthcare GmbHRadiology
April 10, 2026Overjet Iris Intelligent Imaging SystemOverjet, Inc.Radiology
April 10, 2026TRIOS Dx (R1)3Shape TRIOS A/SDental
April 9, 2026Seaman Pro/SeamanCheckcells, Inc.Hematology
April 7, 2026ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.Cardiovascular
April 6, 20266450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.Radiology
April 3, 2026uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.Radiology
April 3, 2026MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.Gastroenterology-Urology
April 1, 2026CoLumbo C-SpineSmart Soft Healthcare ADRadiology
March 30, 2026AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.Radiology
March 28, 2026ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.Cardiovascular
March 27, 2026Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.Radiology
March 27, 2026Butterfly Gestational Age ToolButterfly Network, Inc.Radiology
March 27, 2026Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCRadiology
March 27, 2026EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiology
March 27, 2026Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
March 27, 2026S-scan Open (100001800)Esaote, S.p.A.Radiology
March 27, 2026Contour ProtégéAI+Mim Software, Inc.Radiology
March 26, 2026Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.Neurology
March 26, 2026Lunit INSIGHT DBT (V1.2)Lunit, Inc.Radiology
March 26, 2026SwiftMRAirs Medical, Inc.Radiology
March 24, 2026TriniasShimadzu CorporationRadiology
March 24, 2026JLK-NCCTJLK, Inc.Radiology
March 24, 2026LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
March 23, 2026CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd.Radiology
March 23, 2026True Definition DLGe Healthcare Japan CorporationRadiology
March 20, 2026Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLCRadiology
March 20, 2026SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.Radiology
March 19, 2026AutoContour (RADAC V5)Radformation, Inc.Radiology
March 18, 2026syngo.via RT Image Suite VC10Varian Medical Systems, Inc.Radiology
March 17, 2026Tyto Insights for Eardrum Bulging DetectionTyto Care , Ltd.Ear Nose & Throat
March 17, 2026EchoNavigator R5.0Philips Medical Systems Nederland B.V.Radiology
March 16, 2026SurgiCount+ SystemStryker InstrumentsGeneral Hospital
March 16, 2026Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics IncorporatedRadiology
March 16, 2026Sonio Detect (v3)SonioRadiology
March 13, 2026InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.Radiology
March 13, 2026Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems CorporationRadiology
March 12, 2026Tyto Stethoscope (G3)Tyto Care , Ltd.Cardiovascular
March 12, 2026Deep Capsule® (Deep Capsule US)Digestaid - Artificial Intelligence Development SAGastroenterology-Urology
March 10, 2026Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems CorporationRadiology
March 9, 2026LiverMultiScan (v6.0)Perspectum, Ltd.Radiology
March 8, 2026Onera SleepMap (SLEEPMAP)Onera B.V.Neurology
March 6, 2026Bunkerhill Contrast CACBunkerHill HealthRadiology
March 6, 2026Bunkerhill Contrast AVCBunkerHill HealthRadiology
March 6, 2026VELYS™ Hip NavigationDepuy Ireland UCRadiology
March 5, 2026EarliPoint AssessmentEarlitec DiagnosticsNeurology
March 5, 2026CEPHX3DOrca Dental AI , Ltd.Radiology
March 5, 2026AV Cardiac CTPhilips Medical Systems Nederland B.V.Radiology
March 5, 2026Magnifico Open (100009900)Esaote, S.p.A.Radiology
March 4, 2026QT Scanner 2000 Model AQT Imaging Holdings, Inc.Radiology
March 3, 2026Claire™ OCT SystemPerimeter Medical Imaging Ai, Inc.General and Plastic Surgery
March 3, 2026Annalise EnterpriseHarrison-AI Medical Pty, Ltd.Radiology
March 2, 2026Clarius Ejection Fraction AIClarius Mobile Health Corp.Radiology
February 27, 2026Ligence HeartLigence UabRadiology
February 26, 2026BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd.Radiology
February 24, 2026AI Platform 2.2 (AIP002)Exo ImagingRadiology
February 23, 2026Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including UpgradesPhilips Medical Systems Nederland B.V.Radiology
February 23, 2026MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance , Ltd.Radiology
February 20, 2026CARTO™ 3 EP Navigation System V8.4Biosense Webster, Inc.Cardiovascular
February 20, 2026CARA SystemCara Medical, Ltd.Radiology
February 19, 2026Monaco RTP System (6.3)Elekta Solutions ABRadiology
February 13, 2026PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)Cardiovascular
February 13, 2026uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.Radiology
February 12, 2026Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.Neurology
February 11, 2026Delivery Date AIUltrasound AIRadiology
February 11, 2026AI4CMR v2.0Ai4medimaging Medical Solutions S.A.Radiology
February 10, 2026MI View&GOSiemens Medical Solutions USA, Inc.Radiology
February 6, 2026Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.Cardiovascular
February 6, 2026SafeBeat Rx AppSafeBeat Rx, Inc.Cardiovascular
February 6, 2026Athelas HomeAthelas, Inc.Hematology
February 6, 2026Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median TechnologiesRadiology
February 6, 2026SIGNA™ BoltGe Medical Systems, LLCRadiology
February 5, 2026SIGNA™ Sprint SelectGe Medical Systems, LLCRadiology
February 4, 2026Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASOrthopedic
February 2, 2026Vital SignsOxehealth LimitedCardiovascular
January 30, 2026RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxRadiology
January 29, 2026Surgical Reality ViewerMedicalvr B.V.Radiology
January 29, 2026Neurophet AQUA AD PlusNeurophet., Inc.Radiology
January 28, 2026Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.Radiology
January 27, 2026BriefCase-TriageAidoc Medical , Ltd.Radiology
January 23, 2026BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.Cardiovascular
January 23, 2026AccuContour 4.0Manteia Technologies Co., Ltd.Radiology
January 22, 2026Perin Health System (PHD80060-2)Perin Health Devices, LLCCardiovascular
January 22, 2026PhenoMATRIXCopan Wasp SrlMicrobiology
January 22, 2026AV VascularPhilips Medical Systems Nederland B.V.Radiology
January 22, 2026AI-Rad Companion Brain MRSiemens Healthcare GmbHRadiology
January 20, 2026uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.Radiology
January 16, 2026qXR-DetectQure.Ai TechnologiesRadiology
January 16, 2026Imagine® Enterprise SuiteSoftlink International Private LimitedRadiology
January 15, 2026DiagnocatDGNCT, LLCRadiology
January 15, 2026BIOGRAPH OneSiemens Healthineers AGRadiology
January 15, 2026EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)Elekta Solutions ABRadiology
January 13, 2026VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.Radiology
January 12, 2026Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.Orthopedic
January 11, 2026SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.Neurology
January 9, 2026Corvair MonzaAliveCor, Inc.Cardiovascular
January 8, 2026LOGIQ TotusGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
January 7, 2026DS Core DetectDentsply Sirona, Inc.Radiology
January 7, 2026BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd.Radiology
January 7, 2026LOGIQ FortisGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
January 5, 2026HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.Radiology
December 30, 2025TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.Radiology
December 23, 2025AIR Recon DLGe Medical Systems, LLCRadiology
December 23, 2025ART-Plan+ (v3.1.0)Therapanacea SasRadiology
December 22, 2025PeekMed webPeek Health, S.A.Radiology
December 22, 2025SKOUT systemIterative HealthGastroenterology-Urology
December 22, 2025BioticsAIBioticsai, Inc.Radiology
December 22, 2025Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiology
December 19, 2025AlzevitaTOPIA MEDTECH LIMITEDRadiology
December 19, 2025eMurmur Heart AICsd LabsCardiovascular
December 19, 2025MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseSiemens Healthcare GmbHRadiology
December 19, 2025AI-CVDHeartLung CorporationRadiology
December 18, 2025MediAI-BACrescom Co., Ltd.Radiology
December 18, 2025Assert-IQ (DM5100)Abbott MedicalCardiovascular
December 18, 2025PVAD IQ SoftwareUltrasight , Ltd.Radiology
December 17, 2025UltraSight GuidanceUltrasight , Ltd.Radiology
December 17, 2025Neosoma Brain MetsNeosoma, Inc.Radiology
December 16, 2025IRISegIntuitive Surgical, Inc.Radiology
December 16, 2025prolaio eVO2peak Module (Version 1.0)Prolaio, Inc.Cardiovascular
December 12, 2025Swoop® Portable MR Imaging® SystemHyperfine, Inc.Radiology
December 11, 2025CogNet AI-MT+Medcognetics, Inc.Radiology
December 11, 2025DeepRhythmAIMedicalgorithmics S.A.Cardiovascular
December 10, 2025SANSA HSATHuxley MedicalAnesthesiology
December 9, 2025INFINITT DPSInfinitt Healthcare Co., Ltd.Pathology
December 8, 2025Fetal EchoScan (v1.2)BrightheartRadiology
December 8, 2025Ceribell Delirium Monitor SystemCeribell, Inc.Neurology
December 5, 2025Personalized Therapy Comfort Settings (PTCS)ResMed CorpAnesthesiology
December 5, 2025ARTAssistantManteia Technologies Co., Ltd.Radiology
December 5, 2025Overjet CBCT AssistOverjet, Inc.Radiology
December 5, 2025Gastric AlimetryAlimetry , Ltd.Gastroenterology-Urology
December 3, 2025AVIEW Lung Nodule CADCoreline Soft Co.,LtdRadiology
December 2, 2025Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak MedicalRadiology
December 1, 2025Cartesion Prime (PCD-1000A/3) V10.21Canon Medical Systems CorporationRadiology
November 28, 2025CT VScore+Canon Medical Informatics, Inc.Radiology
November 26, 2025OEC One CFDGe Hualun Medical Systems Co. , Ltd.Radiology
November 25, 2025Scaida BrainCT-ICH (v1.0)Mlhealth 360Radiology
November 25, 20257600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.P.A.Radiology
November 25, 2025FEops HEARTguide Simulation ApplicationFeops NVCardiovascular
November 24, 2025Voluson Expert 18; Voluson Expert 20; Voluson Expert 22Ge Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
November 24, 2025a2z-Unified-TriageA2z Radiology Ai, Inc.Radiology
November 21, 2025CardioVisionIcardio.AiCardiovascular
November 21, 2025Nelli (Version 7.11)Neuro Event Labs OYNeurology
November 21, 2025Senographe Pristina 3DGE HealthcareRadiology
November 20, 2025MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.Radiology
November 17, 2025DTX Studio AssistNobel Biocare C/O Medicim NVRadiology
November 17, 2025DeepRESPNox Medical EhfNeurology
November 14, 2025Second Opinion® PanoramicPearl, Inc.Radiology
November 14, 2025AutoDensityEos ImagingRadiology
November 12, 2025PeekMed webPeek Health, S.A.Radiology
November 7, 2025SugarBug (1.x)Bench7, Inc.Radiology
November 7, 2025Fibresolve (with PCCP)Imvaria, Inc.Radiology
November 6, 2025BriefCase-TriageAidoc Medical , Ltd.Radiology
November 3, 20253mensio WorkstationPie Medical Imaging BVRadiology
November 3, 2025Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak MedicalRadiology
October 31, 2025Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems CorporationRadiology
October 30, 2025AiORTA - PlanViTAA Medical Solutions, Inc.Radiology
October 29, 2025LOGIQ E10Ge Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
October 29, 2025LOGIQ E10sGe Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
October 29, 2025SANSA HSATHuxley MedicalAnesthesiology
October 28, 2025Aurora EV ICD (DVEA3E4)Medtronic, Inc.Cardiovascular
October 28, 2025Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IMedtronic Cardiac Rhythm Disease ManagementCardiovascular
October 27, 2025cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.Radiology
October 24, 2025Syngo Carbon Clinicals (VA41)Siemens Healthineers AGRadiology
October 23, 2025TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.Radiology
October 22, 2025ANDI 2.0Imeka Solutions, Inc.Radiology
October 20, 2025brAIn™ Shoulder PositioningAvatar MedicalRadiology
October 17, 2025X9 Ultrasound SystemX9, Inc.Radiology
October 17, 2025X1-FFRSpectrawave, Inc.Radiology
October 10, 2025Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems CorporationRadiology
October 10, 2025HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept BioroboticsGeneral and Plastic Surgery
October 9, 2025EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiology
October 7, 2025AIAS CephalonMetamorphosis GmbHRadiology
October 6, 2025BlineSlideDeep Breathe, Inc.Radiology
October 3, 2025Bunkerhill MACBunkerhill HealthRadiology
October 3, 2025MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.Gastroenterology-Urology
October 3, 2025xvision Spine systemAugmedics, Ltd.Neurology
October 2, 2025LungQ 4Thirona BVRadiology
September 29, 2025SMART PCFDDisior LtdRadiology
September 29, 2025SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.Neurology
September 26, 2025Ligence HeartLigence, UABRadiology
September 25, 2025uMR 680Shanghai United Imaging Healthcare Co., Ltd.Radiology
September 25, 2025Brain WMHQuantib BVRadiology
September 23, 2025SwiftSight-BrainAIRS Medical Inc.Radiology
September 23, 2025Rapid Aortic MeasurementsiSchemaView, Inc.Radiology
September 19, 2025uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.Radiology
September 19, 2025Videa Dental AIVideaHealth Inc.Radiology
September 19, 2025Bunkerhill ECG-EFBunkerHill HealthCardiovascular
September 18, 2025Axial3D InsightAxial Medical Printing LimitedRadiology
September 17, 2025ECHELON SynergyFujifilm CorporationRadiology
September 17, 2025Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)AbbottCardiovascular
September 15, 2025InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.Radiology
September 12, 2025CADDIEOdin Medical LimitedGastroenterology-Urology
September 12, 2025Volta AF-Xplorer IIVolta MedicalCardiovascular
September 12, 2025FETOLYDiagnolyRadiology
September 12, 2025Stethophone ProSparrow Acoustics, Inc.Cardiovascular
September 11, 2025SIGNA™ SprintGE Medical Systems, LLCRadiology
September 11, 2025Hypertension Notification Feature (HTNF)Apple Inc.Cardiovascular
September 11, 2025Mazor X System / Mazor X Stealth EditionMazor Robotics Ltd.Neurology
September 10, 2025AngioWaveNetAngiowave Imaging, Inc.Radiology
September 9, 2025Segmentron ViewerDGNCT, LLCRadiology
September 9, 2025MuscleView 2.0Springbok, Inc. (dba Springbok Analytics)Radiology
September 8, 2025BioTraceIO Vision (V1.7)Techsomed Medical TechnologiesRadiology
September 8, 2025qER-CTA (v1.0)Qure.ai TechnologiesRadiology
September 4, 2025Rapid Obstructive Hydrocephalus, Rapid OHiSchemaView Inc.Radiology
September 4, 2025Dose+ (1.0)Mvision AI OyRadiology
September 4, 2025Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte. Ltd.Radiology
September 3, 2025Tempus PixelArterys, Inc.Radiology
September 2, 2025OsteoSight™ Hip (v1)Naitive Technologies LtdRadiology
September 2, 2025VELMENI for DENTISTS (V4D)Velmeni Inc.Radiology
August 29, 2025Sonosite LX and Sonosite PX Ultrasound SystemsFujifilm Sonosite IncRadiology
August 29, 2025GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology Inc.Pathology
August 29, 2025SurgiTwinTwinsightRadiology
August 29, 2025PRAEVAorta®2NureaRadiology
August 28, 2025Definium Tempo SelectGE Hualun Medical Systems Co., LtdRadiology
August 27, 2025Vital SignsOxehealth LimitedCardiovascular
August 26, 2025Brainomix 360 Triage StrokeBrainomix LimitedRadiology
August 22, 2025GBrain MRIGalileo CDS, IncRadiology
August 22, 2025MammoScreen BDTherapixelRadiology
August 21, 2025Vista OS, Vista AI Scan, RTHawkVista AI, Inc.Radiology
August 20, 2025Methinks CTA StrokeMethinks Software S.L.Radiology
August 20, 2025Salix Coronary Plaque (V1.0.0)Artrya LimitedRadiology
August 20, 2025ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.Radiology
August 15, 2025VEA Align; spineEOSEOS imagingRadiology
August 15, 2025NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S.Anesthesiology
August 15, 2025CHLOE BLASTFairtility Ltd.Obstetrics and Gynecology
August 12, 2025DS Core DiagnosisDentsply Sirona Inc.Radiology
August 12, 2025Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.Cardiovascular
August 11, 2025Saige-DxDeepHealth, Inc.Radiology
August 7, 2025UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)Radiology
August 6, 2025Cardiologs Holter PlatformPhilips France CommercialCardiovascular
August 5, 2025uMR JupiterShanghai United Imaging Healthcare Co., Ltd.Radiology
August 1, 2025Revolution VibeGE Medical Systems, LLCRadiology
July 31, 2025Genius AI Detection 2.0Hologic, Inc.Radiology
July 31, 2025YSIO X.preeSiemens Medical SolutionsRadiology
July 31, 2025ArteraAI ProstateArtera Inc.Pathology
July 30, 2025Voxel Dosimetry (00859873006226)Hermes Medical Solutions ABRadiology
July 28, 2025ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.Cardiovascular
July 25, 2025Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary care Diagnostics,Radiology
July 24, 2025EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiology
July 23, 2025Neuro Insight V1.0Olea Medical S.A.S.Radiology
July 22, 2025Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiology
July 22, 2025GyriCalc (Version 1.0.0)NeuroSpectrum Insights Corp.Radiology
July 18, 2025HeartFlow AnalysisHeartFlow, Inc.Cardiovascular
July 18, 2025V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.Radiology
July 17, 2025uMR UltraShanghai United Imaging Healthcare Co., Ltd.Radiology
July 17, 2025uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.Radiology
July 16, 2025uMR 680Shanghai United Imaging Healthcare Co., Ltd.Radiology
July 16, 2025Rapid CTA 360iSchemaViewRadiology
July 16, 2025EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
July 15, 2025Tempus ECG-Low EFTempus AI, Inc.Cardiovascular
July 14, 2025PeekMed webPeek Health, S.A.Radiology
July 14, 2025LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical SolutionsRadiology
July 10, 2025Vivid PioneerGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiology
July 8, 2025TumorSight VizSimBioSys, Inc.Radiology
July 7, 2025TAVIPILOTCaranx MedicalRadiology
July 3, 2025MammoScreen® (4)TherapixelRadiology
July 3, 2025syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.Radiology
July 1, 2025StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging Inc.Radiology
July 1, 2025Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill HealthRadiology
July 1, 2025Felix NeuroAI SystemFasikl IncorporatedNeurology
June 30, 2025PIUR tUS insidePIUR Imaging GmbHRadiology
June 30, 2025Synapse PACS (7.5)FUJIFILM Healthcare Americas CorporationRadiology
June 30, 2025EchoConfidence (USA)Mycardium AI LimitedRadiology
June 27, 2025Maestro System (REF100)Moon SurgicalGastroenterology-Urology
June 27, 2025X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.Hematology
June 24, 2025HyperSnap Surgical System (HSS)Hypervision SurgicalGastroenterology-Urology
June 20, 2025TMINI Miniature Robotic SystemTHINK Surgical, Inc.Neurology
June 20, 2025Us2.caEko.Ai Pte Ltd. D/B/A Us2.AiCardiovascular
June 19, 2025EpiMonitorEmpatica SrlNeurology
June 18, 2025EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLCRadiology
June 18, 20256600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote S.p.A.Radiology
June 18, 2025CardIQ SuiteGE Medical Systems SCSRadiology
June 17, 2025RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RTBrainlab AGRadiology
June 16, 2025MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance , Ltd.Radiology
June 16, 2025MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbHRadiology
June 16, 2025Methinks NCCT StrokeMethinks Software S.L.Radiology
June 15, 2025Withings ECG AppWithingsCardiovascular
June 13, 2025Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)Brainlab AGRadiology
June 12, 2025Second Opinion® CSPearl Inc.Radiology
June 12, 2025AuroraGE Medical Systems IsraelRadiology
June 10, 2025Viz Subdural+, Viz SUBDURAL PLUSViz.ai, Inc.Radiology
June 6, 2025Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc.Radiology
June 6, 2025Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.R.L.Cardiovascular
June 5, 2025BrightHeart View ClassifierBrightHeartRadiology
June 5, 2025Sonic DLGE Medical Systems, LLCRadiology
June 4, 2025Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemPhilips Medical Systems Nederland B.V.Radiology
June 4, 2025TraumaCad Neo (1.1)Brainlab Ltd.Radiology
June 4, 2025PhysCade SystemPhysCade, Inc.Cardiovascular
May 30, 2025AudaxCeph Cephalogram Analysis SoftwareAudax d.o.o.Radiology
May 30, 2025Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.Radiology
May 30, 2025Opulus™ Lymphoma PrecisionRoche Molecular Systems, Inc.Radiology
May 30, 2025Allix5Clairity, Inc.Radiology
May 30, 2025BriefCase-TriageAidoc Medical, Ltd.Radiology
May 30, 2025LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., LTD.Hematology
May 29, 2025Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary care DiagnosticsRadiology
May 28, 2025CoLumboXSmart Soft Healthcare ADRadiology
May 28, 2025TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.Radiology
May 28, 2025Rapid MLSiSchemaview Inc.Radiology
May 27, 2025DeepRhythmAIMedicalgorithmics S.A.Cardiovascular
May 23, 2025Accuro 3SRivanna Medical, Inc.Radiology
May 23, 2025DEEPECHODeepEchoRadiology
May 23, 2025Clever OneEwoosoft Co., LtdRadiology
May 23, 2025Second Opinion® 3DPearl, Inc.Radiology
May 21, 2025EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiology
May 21, 2025Synapse 3D Base Tools (V7.0)FUJIFILM CorporationRadiology
May 21, 2025InVision Precision Cardiac AmyloidInVision Medical Technology CorporationCardiovascular
May 21, 2025uMR OmegaShanghai United Imaging Healthcare Co., Ltd.Radiology
May 21, 2025Swoop® Portable MR Imaging® SystemHyperfine, Inc.Radiology
May 20, 2025SCENARIA View Phase 5.0FUJIFILM CorporationRadiology
May 16, 2025uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co.,Ltd.Radiology
May 16, 20256450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote S.p.A.Radiology
May 16, 2025OTS HipOrtoma ABNeurology
May 16, 2025InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.Radiology
May 14, 2025Smile Dx®Cube Click, Inc.Radiology
May 14, 2025Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.Radiology
May 9, 2025Volta AF-XplorerVolta MedicalCardiovascular
May 9, 2025LensHooke X12 PRO Semen Analysis SystemBonraybio Co., LTD.Hematology
May 9, 2025EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLCRadiology
May 9, 2025SKOUT systemIterative HealthGastroenterology-Urology
May 9, 2025Second Opinion® BLEPearl Inc.Radiology

Methods and sources

FDA's list covers devices that use artificial intelligence and have been authorized for marketing through 510(k) clearance, De Novo or premarket approval. FDA says the list is not exhaustive. Company names are lightly normalized (suffixes such as Inc. and LLC removed) for the company count.

Source: US Food and Drug Administration, Artificial Intelligence-Enabled Medical Devices, decisions through June 29, 2026. Retrieved November 4, 2026. Checked weekly. Download the data (JSON).

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