Cleared in 2026
Radiology AI devices with a 2026 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
AiORTA - Plan v2.0
🇨🇦ViTAA Medical Solutions, Inc.
MR image reconstruction/enhancement
Spectral CT Verida Family
🇮🇱Philips Medical Systems Technologies , Ltd.
System, X-Ray, Tomography, Computed
Butterfly Gestational Age Tool
🇺🇸Butterfly Network, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
Automated Aortic Stenosis Software (AutoAS)
🇺🇸GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
S-scan Open (100001800)
🇮🇹Esaote, S.p.A.
System, Nuclear Magnetic Resonance Imaging
Contour ProtégéAI+
🇺🇸Mim Software, Inc.
RT auto-contouring
Lunit INSIGHT DBT (V1.2)
🇰🇷Lunit, Inc.
Breast CAD (tomosynthesis)
SwiftMR
🇰🇷Airs Medical, Inc.
MR image reconstruction/enhancement
Trinias
🇯🇵Shimadzu Corporation
Interventional Fluoroscopic X-Ray System
JLK-NCCT
🇰🇷JLK, Inc.
Triage & notification (CADt)
LOGIQ 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 Power
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
CT Rembra RT; CT Areta RT; CT Rembra
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
True Definition DL
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
Photonova Spectra, Photonova Spectra Select
🇺🇸Ge Medical Systems, LLC
System, X-Ray, Tomography, Computed
SOMATOM X.cite; SOMATOM X.ceed
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
AutoContour (RADAC V5)
🇺🇸Radformation, Inc.
RT auto-contouring
syngo.via RT Image Suite VC10
🇺🇸Varian Medical Systems, Inc.
System, Planning, Radiation Therapy Treatment
EchoNavigator R5.0
🇳🇱Philips Medical Systems Nederland B.V.
MR image reconstruction/enhancement
Data Analysis Facilitation Suite (DAFS)
Voronoi Health Analytics Incorporated
MR image reconstruction/enhancement
Sonio Detect (v3)
🇨🇫Sonio
System, Imaging, Pulsed Doppler, Ultrasonic
InferCare RECIST
Beijing Infervision Healthcare Medical Technology Co., Ltd.
MR image reconstruction/enhancement
Aquilion ServeSP (TSX-307B) V2.0
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
🇯🇵Canon Medical Systems Corporation
Interventional Fluoroscopic X-Ray System
LiverMultiScan (v6.0)
🇬🇧Perspectum, Ltd.
System, Nuclear Magnetic Resonance Imaging
Bunkerhill Contrast CAC
🇺🇸BunkerHill Health
System, X-Ray, Tomography, Computed
Bunkerhill Contrast AVC
🇺🇸BunkerHill Health
System, X-Ray, Tomography, Computed
VELYS Hip Navigation
🇮🇪Depuy Ireland UC
MR image reconstruction/enhancement
CEPHX3D
Orca Dental AI , Ltd.
MR image reconstruction/enhancement
