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.
Digital Color Doppler Ultrasound System (P60 Series)
🇨🇳Sonoscape Medical Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
Second Opinion CC
🇺🇸Pearl, Inc.
Analyzer, Medical Image
Cardiac Guidance
Caption Health, Inc.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
uCT 550
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
🇮🇱Arineta Ltd.
System, X-Ray, Tomography, Computed
ScreenDx
Imvaria, Inc.
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
uCT 780
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
Soteria E-View
🇺🇸Omega Medical Imaging, LLC
System, X-Ray, Fluoroscopic, Image-Intensified
Brainomix 360 e-CTA
🇬🇧Brainomix Limited
System, Image Processing, Radiological
Clarify DL
🇮🇱GE Medical Systems Israel, Functional Imaging
System, Image Processing, Radiological
JLK-ICH
🇰🇷JLK, Inc.
Triage & notification (CADt)
Ortho AI
Ortho AI LLC
MR image reconstruction/enhancement
Ezra Flash
🇺🇸Ezra AI, Inc.
MR image reconstruction/enhancement
