Cleared in 2025
Radiology AI devices with a 2025 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
SwiftSight-Brain
🇰🇷Airs Medical, Inc.
MR image reconstruction/enhancement
Rapid Aortic Measurements
🇺🇸iSchemaView, Inc.
MR image reconstruction/enhancement
uDR Aurora CX
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Stationary
Videa Dental AI
🇺🇸VideaHealth Inc.
Analyzer, Medical Image
Axial3D Insight
🇬🇧Axial Medical Printing Limited
MR image reconstruction/enhancement
ECHELON Synergy
🇯🇵Fujifilm Corporation
System, Nuclear Magnetic Resonance Imaging
InferOperate Suite
Beijing Infervision Healthcare Medical Technology Co., Ltd.
MR image reconstruction/enhancement
FETOLY
🇫🇷Diagnoly
System, Imaging, Pulsed Doppler, Ultrasonic
SIGNA Sprint
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
AngioWaveNet
🇺🇸Angiowave Imaging, Inc.
MR image reconstruction/enhancement
Segmentron Viewer
🇺🇸DGNCT, LLC
MR image reconstruction/enhancement
MuscleView 2.0
Springbok, Inc. (dba Springbok Analytics)
System, Nuclear Magnetic Resonance Imaging
BioTraceIO Vision (V1.7)
Techsomed Medical Technologies
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
qER-CTA (v1.0)
🇮🇳Qure.Ai Technologies
Triage & notification (CADt)
Rapid Obstructive Hydrocephalus, Rapid OH
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
Dose+ (1.0)
🇫🇮Mvision AI Oy
System, Planning, Radiation Therapy Treatment
Careverse CoronaryDoc (Careverse CoronaryDoc)
Careverse Technology Pte. Ltd.
MR image reconstruction/enhancement
Tempus Pixel
🇺🇸Arterys, Inc.
MR image reconstruction/enhancement
OsteoSight Hip (v1)
🇬🇧Naitive Technologies Ltd
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
VELMENI for DENTISTS (V4D)
Velmeni Inc.
Analyzer, Medical Image
Sonosite LX and Sonosite PX Ultrasound Systems
🇺🇸Fujifilm Sonosite Inc
System, Imaging, Pulsed Doppler, Ultrasonic
SurgiTwin
Twinsight
System, Image Processing, Radiological
PRAEVAorta®2
Nurea
MR image reconstruction/enhancement
Definium Tempo Select
Ge Hualun Medical Systems Co. , Ltd.
System, X-Ray, Stationary
Brainomix 360 Triage Stroke
🇬🇧Brainomix Limited
Triage & notification (CADt)
GBrain MRI
Galileo CDS, Inc
MR image reconstruction/enhancement
MammoScreen BD
🇺🇸Therapixel
MR image reconstruction/enhancement
Vista OS, Vista AI Scan, RTHawk
🇺🇸Vista AI, Inc.
System, Nuclear Magnetic Resonance Imaging
Methinks CTA Stroke
Methinks Software S.L.
Triage & notification (CADt)
Salix Coronary Plaque (V1.0.0)
Artrya Limited
MR image reconstruction/enhancement
