Radiology · 2025Radiology AI devices by month in 2025: Jan 19, Feb 24, Mar 20, Apr 22, May 30, Jun 19, Jul 23, Aug 17, Sep 24, Oct 17, Nov 17, Dec 22
FDA-cleared AI devices for radiology 2025
2025 has 254 radiology AI devices, 38.8% more than 2024 (183). That is 20.7% of the 1,230 radiology devices on the FDA list, and 75.8% of all AI-device decisions dated 2025. The most active were GE Medical Systems Ultrasound and Primary Care Diagnostics (10), Shanghai United Imaging Healthcare Co., Ltd. (10), Philips Ultrasound, LLC (9). The newest is TruSPECT Processing Station from Spectrum Dynamics Medical, Ltd., decided on December 30, 2025.
2542025 devices
156Companies
75.8%Of all 2025 AI devices
20.7%Of all radiology
Companies in 2025
By month
JanFebMarAprMayJunJulAugSepOctNovDec
Product codes
QIHAutomated Radiological Image Processing Software93IYNSystem, Imaging, Pulsed Doppler, Ultrasonic29LNHSystem, Nuclear Magnetic Resonance Imaging23QASRadiological Computer-Assisted Triage And Notification Software15MYNAnalyzer, Medical Image14JAKSystem, X-Ray, Tomography, Computed13LLZSystem, Image Processing, Radiological11MUJSystem, Planning, Radiation Therapy Treatment6All 254 devices
- TruSPECT Processing StationSpectrum Dynamics Medical, Ltd. · Radiology
- AIR Recon DLGe Medical Systems, LLC · Radiology
- ART-Plan+ (v3.1.0)Therapanacea Sas · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- BioticsAIBioticsai, Inc. · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- AlzevitaTOPIA MEDTECH LIMITED · Radiology
- MAGNETOM 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 GmbH · Radiology
- AI-CVDHeartLung Corporation · Radiology
- MediAI-BACrescom Co., Ltd. · Radiology
- PVAD IQ SoftwareUltrasight , Ltd. · Radiology
- UltraSight GuidanceUltrasight , Ltd. · Radiology
- Neosoma Brain MetsNeosoma, Inc. · Radiology
- IRISegIntuitive Surgical, Inc. · Radiology
- Swoop® Portable MR Imaging® SystemHyperfine, Inc. · Radiology
- CogNet AI-MT+Medcognetics, Inc. · Radiology
- Fetal EchoScan (v1.2)Brightheart · Radiology
- ARTAssistantManteia Technologies Co., Ltd. · Radiology
- Overjet CBCT AssistOverjet, Inc. · Radiology
- AVIEW Lung Nodule CADCoreline Soft Co.,Ltd · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- Cartesion Prime (PCD-1000A/3) V10.21Canon Medical Systems Corporation · Radiology
- CT VScore+Canon Medical Informatics, Inc. · Radiology
- OEC One CFDGe Hualun Medical Systems Co. , Ltd. · Radiology
- Scaida BrainCT-ICH (v1.0)Mlhealth 360 · Radiology
- 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.P.A. · Radiology
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22Ge Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- a2z-Unified-TriageA2z Radiology Ai, Inc. · Radiology
- Senographe Pristina 3DGE Healthcare · Radiology
- MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd. · Radiology
- DTX Studio AssistNobel Biocare C/O Medicim NV · Radiology
- Second Opinion® PanoramicPearl, Inc. · Radiology
- AutoDensityEos Imaging · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- SugarBug (1.x)Bench7, Inc. · Radiology
- Fibresolve (with PCCP)Imvaria, Inc. · Radiology
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- 3mensio WorkstationPie Medical Imaging BV · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation · Radiology
- AiORTA - PlanViTAA Medical Solutions, Inc. · Radiology
- LOGIQ E10Ge Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- LOGIQ E10sGe Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc. · Radiology
- Syngo Carbon Clinicals (VA41)Siemens Healthineers AG · Radiology
- TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · Radiology
- ANDI 2.0Imeka Solutions, Inc. · Radiology
- brAIn Shoulder PositioningAvatar Medical · Radiology
- X9 Ultrasound SystemX9, Inc. · Radiology
- X1-FFRSpectrawave, Inc. · Radiology
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- AIAS CephalonMetamorphosis GmbH · Radiology
- BlineSlideDeep Breathe, Inc. · Radiology
- Bunkerhill MACBunkerhill Health · Radiology
- LungQ 4Thirona BV · Radiology
- SMART PCFDDisior Ltd · Radiology
- Ligence HeartLigence, UAB · Radiology
- uMR 680Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Brain WMHQuantib BV · Radiology
- SwiftSight-BrainAIRS Medical Inc. · Radiology
- Rapid Aortic MeasurementsiSchemaView, Inc. · Radiology
- uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Videa Dental AIVideaHealth Inc. · Radiology
- Axial3D InsightAxial Medical Printing Limited · Radiology
- ECHELON SynergyFujifilm Corporation · Radiology
- InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · Radiology
- FETOLYDiagnoly · Radiology
- SIGNA SprintGE Medical Systems, LLC · Radiology
- AngioWaveNetAngiowave Imaging, Inc. · Radiology
- Segmentron ViewerDGNCT, LLC · Radiology
- MuscleView 2.0Springbok, Inc. (dba Springbok Analytics) · Radiology
- BioTraceIO Vision (V1.7)Techsomed Medical Technologies · Radiology
- qER-CTA (v1.0)Qure.ai Technologies · Radiology
- Rapid Obstructive Hydrocephalus, Rapid OHiSchemaView Inc. · Radiology
- Dose+ (1.0)Mvision AI Oy · Radiology
- Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte. Ltd. · Radiology
- Tempus PixelArterys, Inc. · Radiology
- OsteoSight Hip (v1)Naitive Technologies Ltd · Radiology
- VELMENI for DENTISTS (V4D)Velmeni Inc. · Radiology
- Sonosite LX and Sonosite PX Ultrasound SystemsFujifilm Sonosite Inc · Radiology
- SurgiTwinTwinsight · Radiology
- PRAEVAorta®2Nurea · Radiology
- Definium Tempo SelectGE Hualun Medical Systems Co., Ltd · Radiology
- Brainomix 360 Triage StrokeBrainomix Limited · Radiology
- GBrain MRIGalileo CDS, Inc · Radiology
- MammoScreen BDTherapixel · Radiology
- Vista OS, Vista AI Scan, RTHawkVista AI, Inc. · Radiology
- Methinks CTA StrokeMethinks Software S.L. · Radiology
- Salix Coronary Plaque (V1.0.0)Artrya Limited · Radiology
- ACUSON 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
- VEA Align; spineEOSEOS imaging · Radiology
- DS Core DiagnosisDentsply Sirona Inc. · Radiology
- Saige-DxDeepHealth, Inc. · Radiology
- UNiD Spine AnalyzerMedicrea International S.A.S. (Medtronic) · Radiology
- uMR JupiterShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Revolution VibeGE Medical Systems, LLC · Radiology
- Genius AI Detection 2.0Hologic, Inc. · Radiology
- YSIO X.preeSiemens Medical Solutions · Radiology
- Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB · Radiology
- Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- Neuro Insight V1.0Olea Medical S.A.S. · Radiology
- Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- GyriCalc (Version 1.0.0)NeuroSpectrum Insights Corp. · Radiology
- V8 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
- uMR UltraShanghai United Imaging Healthcare Co., Ltd. · Radiology
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- uMR 680Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Rapid CTA 360iSchemaView · Radiology
- EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions · Radiology
- Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- TumorSight VizSimBioSys, Inc. · Radiology
- TAVIPILOTCaranx Medical · Radiology
- MammoScreen® (4)Therapixel · Radiology
- syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging Inc. · Radiology
- Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health · Radiology
- PIUR tUS insidePIUR Imaging GmbH · Radiology
- Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · Radiology
- EchoConfidence (USA)Mycardium AI Limited · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote S.p.A. · Radiology
- CardIQ SuiteGE Medical Systems SCS · Radiology
- RT 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 AG · Radiology
- MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance , Ltd. · Radiology
- MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · Radiology
- Methinks NCCT StrokeMethinks Software S.L. · Radiology
- Brainlab 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 AG · Radiology
- Second Opinion® CSPearl Inc. · Radiology
- AuroraGE Medical Systems Israel · Radiology
- Viz Subdural+, Viz SUBDURAL PLUSViz.ai, Inc. · Radiology
- Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc. · Radiology
- BrightHeart View ClassifierBrightHeart · Radiology
- Sonic DLGE Medical Systems, LLC · Radiology
- Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemPhilips Medical Systems Nederland B.V. · Radiology
- TraumaCad Neo (1.1)Brainlab Ltd. · Radiology
- AudaxCeph Cephalogram Analysis SoftwareAudax d.o.o. · Radiology
- Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc. · Radiology
- Opulus Lymphoma PrecisionRoche Molecular Systems, Inc. · Radiology
- Allix5Clairity, Inc. · Radiology
- BriefCase-TriageAidoc Medical, Ltd. · Radiology
- Voluson Performance 16; Voluson Performance 18GE Medical Systems Ultrasound and Primary care Diagnostics · Radiology
- CoLumboXSmart Soft Healthcare AD · Radiology
- TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd. · Radiology
- Rapid MLSiSchemaview Inc. · Radiology
- Accuro 3SRivanna Medical, Inc. · Radiology
- DEEPECHODeepEcho · Radiology
- Clever OneEwoosoft Co., Ltd · Radiology
- Second Opinion® 3DPearl, Inc. · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- Synapse 3D Base Tools (V7.0)FUJIFILM Corporation · Radiology
- uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Swoop® Portable MR Imaging® SystemHyperfine, Inc. · Radiology
- SCENARIA View Phase 5.0FUJIFILM Corporation · Radiology
- uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co.,Ltd. · Radiology
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote S.p.A. · Radiology
- InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · Radiology
- Smile Dx®Cube Click, Inc. · Radiology
- Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- Second Opinion® BLEPearl Inc. · Radiology
- Clarius Median Nerve AIClarius Mobile Health Corp. · Radiology
- BrightHeart View ClassifierBrightHeart · Radiology
- Second Opinion® PediatricPearl, Inc. · Radiology
- Fetal EchoScan (v1.1)BrightHeart · Radiology
- Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation · Radiology
- uAngio AVIVA CXShanghai United Imaging Healthcare Co.,Ltd. · Radiology
- Lung AI (LAI001)Exo Inc · Radiology
- Annalise EnterpriseAnnalise-AI · Radiology
- VersaViewerGE Medical Systems SCS · Radiology
- LARALABLARALAB GmbH · Radiology
- Clarius Prostate AIClarius Mobile Health Corp. · Radiology
- SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta Ltd. · Radiology
- GBrain MRIGalileo CDS, Inc · Radiology
- OncospaceOncospace, Inc. · Radiology
- Second Opinion Periapical Radiolucency ContoursPearl Inc. · Radiology
- syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc. · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- cmAngio® (V1.6)CureMetrix, Inc. · Radiology
- BunkerHill BMDBunkerHill Health · Radiology
- HeartFocus (V.1.1.1)Deski · Radiology
- RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3RaySearch Laboratories AB (PUBL) · Radiology
- QFR (3.0)QFR Solutions bv · Radiology
- DeepFoqus (DeepFoqus-Accelerate)Foqus Technologies Inc. · Radiology
- syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · Radiology
- Hi-D Imaging 4TAVRHi-D Imaging AG · Radiology
- MR Contour DLGE HealthCare · Radiology
- TribusConnectTribusMed Beheer BV · Radiology
- AI-Rad Companion Organs RTSiemens Healthcare GmbH · Radiology
- Salix CentralArtrya Limited · Radiology
- V5med Lung AIV5med Inc. · Radiology
- Rayvolve LNAZmed · Radiology
- Rayvolve PTX-PEAZmed · Radiology
- Vent Creativity Knee v1.0 (Hermes)Vent Creativity · Radiology
- brAIn Shoulder PositioningAvatar Medical · Radiology
- AVIEWCoreline Soft Co., Ltd. · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- QP-Prostate® CADQuibim S.L. · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd. · Radiology
- SIGNA Prime EliteGE Medical Systems, LLC · Radiology
- Better Diagnostics Caries Assist (BDCA) Version 1.0Better Diagnostics AI Corp · Radiology
- Cleerly LABS (v2.0)Cleerly, Inc. · Radiology
- LVivo SeamlessDiA Imaging Analysis Ltd. · Radiology
- Prostate MR AI (VA10A)Siemens Healthcare GmbH · Radiology
- Ceevra Reveal 3+Ceevra, Inc. · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd. · Radiology
- JLK-SDHJLK, Inc. · Radiology
- MyomicsPhantomics Inc. · Radiology
- ChestView USGleamer SAS · Radiology
- aiCockpit AI ViewerFovia, Inc. · Radiology
- Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics Ltd. · Radiology
- 3DXRGE Medical Systems SCS · Radiology
- ART-Plan+ (v.3.0.0)Therapanacea SAS · Radiology
- OncoStudio (OS-01)OncoSoft. Co., Ltd. · Radiology
- QuickRadAikenist Technologies Pvt Ltd · Radiology
- ScanDiags Ortho L-Spine MR-QScanDiags AG · Radiology
- Sonio SuspectSonio · Radiology
- EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)Ever Fortune.AI, Co., Ltd. · Radiology
- CaRi-PlaqueCaristo Diagnostics Ltd. · Radiology
- BriefCase-TriageAidoc Medical, Ltd. · Radiology
- Brainomix 360 e-ASPECTSBrainomix Limited · Radiology
- AVIEW CACCoreline Soft Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc. · Radiology
- SubtleHD (1.x)Subtle Medical, Inc. · Radiology
- Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Ultrasound Workspace (UWS 6.0)Philips Ultrasound LLC · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- BoneMetrics (US)Gleamer SAS · Radiology
- Contour ProtégéAI+MIM Software Inc. · Radiology
- Bunkerhill AVCBunkerHill Health · Radiology
- TeraRecon Aorta.CT (1.1.0)TeraRecon, Inc. · Radiology
- Rapid Neuro3DiSchemaView, Inc. · Radiology
- Prenuvo Body CompositionPrenuvo · Radiology
- TechCare TraumaMilvue · Radiology
- Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp. · Radiology
- Second Opinion CCPearl Inc. · Radiology
- Cardiac GuidanceCaption Health, Inc. · Radiology
- uCT 550Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta Ltd. · Radiology
- ScreenDxImvaria, Inc · Radiology
- Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- uCT 780Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Soteria E-ViewOmega Medical Imaging, LLC · Radiology
- Brainomix 360 e-CTABrainomix Limited · Radiology
- Clarify DLGE Medical Systems Israel, Functional Imaging · Radiology
- JLK-ICHJLK, Inc. · Radiology
- Ortho AIOrtho AI LLC · Radiology
- Ezra FlashEzra AI, Inc. · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2025?
254 AI-enabled radiology devices have a final decision dated 2025, from 156 companies.
How does 2025 compare with 2024 for AI radiology devices?
2025 has 254 radiology AI devices, 38.8% more than 2024 (183).
Which companies cleared the most AI radiology devices in 2025?
GE Medical Systems Ultrasound and Primary Care Diagnostics (10), Shanghai United Imaging Healthcare Co., Ltd. (10), Philips Ultrasound, LLC (9).
What was the most recent AI radiology device in 2025?
TruSPECT Processing Station from Spectrum Dynamics Medical, Ltd. (K253532), decided on December 30, 2025. Product code QIH.
Which product codes were most common for AI radiology devices in 2025?
QIH (Automated Radiological Image Processing Software): 93; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 29; LNH (System, Nuclear Magnetic Resonance Imaging): 23.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2025,” https://ai-device-radar.vercel.app/specialty/radiology/2025 (FDA list through 2026-06-29).