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2026-10-14 · Generated from RankToolsMD data

47 FDA AI clearances in 2026 from vendors we rank

The FDA’s AI-enabled device list (currently through June 2026 decisions) shows 47 authorizations dated 2026 from 25 companies whose products appear in our top-5 lists. Each number below links to the FDA database record.

Decision dateDeviceApplicantFDA number
06/26/2026MammoScreen® (5)TherapixelK260714
06/25/2026syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.K253786
06/24/2026Enhanced Boundary for PCCTGe Medical Systems, LLCK253560
06/16/2026ACUSON 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.K260844
06/15/2026LungMapsSiemens Healthineers AGK253690
06/15/2026Saige-DxDeepHealth, Inc.K253825
06/15/2026WatchMate SoftwareAnumana, Inc.K260300
06/12/2026Brainomix 360 HyperdensityBrainomix LimitedK260406
05/22/2026Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc.K260324
05/21/2026BACDeepHealth, Inc.K254131
05/20/2026Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253596
05/15/2026SubtleHD-CT (1.x)Subtle Medical, Inc.K254120
05/14/2026SubtleHD-PET (1.x)Subtle Medical, Inc.K254013
05/04/2026ArteraAI BreastArtera, Inc.K254115
04/30/2026Bayesian Health Sepsis Flagging DeviceBayesian Health, Inc.K250680
04/29/2026syngo Application SoftwareSiemens Medical Solutions USA, Inc.K254184
04/23/2026Lunit INSIGHT MMG (v1.1.10)Lunit, Inc.K260320
04/14/2026Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLCK253502
04/10/2026AI-Rad Companion Organs RTSiemens Healthcare GmbHK252548
04/10/2026syngo Dynamics (VA41F)Siemens Healthcare GmbHK253689
04/10/2026Overjet Iris Intelligent Imaging SystemOverjet, Inc.K253930
04/07/2026ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.K253801
03/28/2026ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.K252360
03/27/2026Butterfly Gestational Age ToolButterfly Network, Inc.K252148
03/27/2026Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK254161
03/27/2026Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction   Processing Unit for MRCanon Medical Systems CorporationK253625
03/27/2026Contour ProtégéAI+Mim Software, Inc.K253270
03/26/2026Lunit INSIGHT DBT (V1.2)Lunit, Inc.K253796
03/26/2026SwiftMRAirs Medical, Inc.K253775
03/24/2026LOGIQ 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 DiagnosticsK260673
03/20/2026Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLCK253520
03/20/2026SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.K253574
03/19/2026AutoContour (RADAC V5)Radformation, Inc.K260509
03/13/2026Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems CorporationK260078
03/10/2026Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV   Extension)Canon Medical Systems CorporationK253584
03/06/2026Bunkerhill Contrast CACBunkerHill HealthK260166
03/06/2026Bunkerhill Contrast AVCBunkerHill HealthK260167
02/24/2026AI Platform 2.2 (AIP002)Exo ImagingK260217
02/10/2026MI View&GOSiemens Medical Solutions USA, Inc.K254016
02/06/2026SIGNA™ BoltGe Medical Systems, LLCK253780
02/05/2026SIGNA™ Sprint SelectGe Medical Systems, LLCK253779
01/22/2026AI-Rad Companion Brain MRSiemens Healthcare GmbHK253057
01/16/2026qXR-DetectQure.Ai TechnologiesK251934
01/15/2026BIOGRAPH OneSiemens Healthineers AGK253023
01/09/2026Corvair MonzaAliveCor, Inc.K252589
01/08/2026LOGIQ TotusGE Medical Systems Ultrasound and Primary Care DiagnosticsK253370
01/07/2026LOGIQ FortisGE Medical Systems Ultrasound and Primary Care DiagnosticsK253366

Clearance applies to the indication in each FDA record, not to every feature a vendor markets. See the live feed.

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