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.
DTX Studio Assist
🇧🇪Nobel Biocare C/O Medicim NV
Analyzer, Medical Image
Second Opinion® Panoramic
🇺🇸Pearl, Inc.
Analyzer, Medical Image
AutoDensity
🇫🇷Eos Imaging
MR image reconstruction/enhancement
PeekMed web
🇵🇹Peek Health, S.A.
MR image reconstruction/enhancement
SugarBug (1.x)
🇺🇸Bench7, Inc.
Analyzer, Medical Image
Fibresolve (with PCCP)
Imvaria, Inc.
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
3mensio Workstation
Pie Medical Imaging BV
MR image reconstruction/enhancement
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
🇺🇸Mighty Oak Medical
System, Image Processing, Radiological
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
🇯🇵Canon Medical Systems Corporation
System, Imaging, Pulsed Doppler, Ultrasonic
AiORTA - Plan
🇨🇦ViTAA Medical Solutions, Inc.
MR image reconstruction/enhancement
LOGIQ E10
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E10s
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
cvi42 Coronary Plaque Software Application
🇨🇦Circle Cardiovascular Imaging, Inc.
MR image reconstruction/enhancement
Syngo Carbon Clinicals (VA41)
🇩🇪Siemens Healthineers AG
MR image reconstruction/enhancement
TeraRecon Cardiovascular.Calcification.CT
🇺🇸Terarecon,Inc.
MR image reconstruction/enhancement
ANDI 2.0
🇨🇦Imeka Solutions, Inc.
MR image reconstruction/enhancement
brAIn Shoulder Positioning
🇺🇸Avatar Medical
MR image reconstruction/enhancement
X9 Ultrasound System
🇺🇸X9, Inc.
Ultrasound Imaging For Vascular Access For Hemodialysis
X1-FFR
🇺🇸Spectrawave, Inc.
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
🇯🇵Canon Medical Systems Corporation
Interventional Fluoroscopic X-Ray System
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
AIAS Cephalon
🇩🇪Metamorphosis GmbH
MR image reconstruction/enhancement
BlineSlide
Deep Breathe, Inc.
MR image reconstruction/enhancement
Bunkerhill MAC
🇺🇸BunkerHill Health
System, X-Ray, Tomography, Computed
LungQ 4
🇳🇱Thirona BV
System, X-Ray, Tomography, Computed
SMART PCFD
Disior Ltd
MR image reconstruction/enhancement
Ligence Heart
Ligence Uab
MR image reconstruction/enhancement
uMR 680
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
Brain WMH
🇳🇱Quantib BV
MR image reconstruction/enhancement
