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.
Clever One
🇰🇷Ewoosoft Co., Ltd
MR image reconstruction/enhancement
Second Opinion® 3D
🇺🇸Pearl, Inc.
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
Synapse 3D Base Tools (V7.0)
🇯🇵Fujifilm Corporation
MR image reconstruction/enhancement
uMR Omega
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
Swoop® Portable MR Imaging® System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
SCENARIA View Phase 5.0
🇯🇵Fujifilm Corporation
System, X-Ray, Tomography, Computed
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
🇮🇹Esaote, S.p.A.
System, Imaging, Pulsed Doppler, Ultrasonic
InferRead Lung CT.AI
🇨🇳Infervision Medical Technology Co., Ltd.
Lung Computed Tomography System, Computer-Aided Detection
Smile Dx®
Cube Click, Inc.
Analyzer, Medical Image
Medical Image Post-processing Software (uOmnispace.CT)
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
Second Opinion® BLE
🇺🇸Pearl, Inc.
MR image reconstruction/enhancement
Clarius Median Nerve AI
🇨🇦Clarius Mobile Health Corp.
MR image reconstruction/enhancement
BrightHeart View Classifier
🇫🇷Brightheart
MR image reconstruction/enhancement
Second Opinion® Pediatric
🇺🇸Pearl, Inc.
Analyzer, Medical Image
Fetal EchoScan (v1.1)
🇫🇷Brightheart
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Vscan Air
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
🇯🇵Canon Medical Systems Corporation
MR image reconstruction/enhancement
uAngio AVIVA CX
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
Interventional Fluoroscopic X-Ray System
Lung AI (LAI001)
Exo Inc
Analyzer, Medical Image
Annalise Enterprise
🇦🇺Annalise.ai
Lesion detection/diagnosis software
VersaViewer
🇫🇷GE Medical Systems SCS
System, Image Processing, Radiological
LARALAB
LARALAB GmbH
MR image reconstruction/enhancement
Clarius Prostate AI
🇨🇦Clarius Mobile Health Corp.
MR image reconstruction/enhancement
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
🇮🇱Arineta Ltd.
System, X-Ray, Tomography, Computed
GBrain MRI
Galileo CDS, Inc
MR image reconstruction/enhancement
Oncospace
Oncospace, Inc.
System, Planning, Radiation Therapy Treatment
Second Opinion Periapical Radiolucency Contours
🇺🇸Pearl, Inc.
Analyzer, Medical Image
