FDA-cleared — AI devices
Radiology AI devices on the FDA's AI-Enabled Device List (the Radiology panel). The list is not comprehensive and lags publication of decision summaries. Information only, never clinical advice.
Opulus Lymphoma Precision
🇺🇸Roche Molecular Systems, Inc.
MR image reconstruction/enhancement
Allix5
🇺🇸Clairity, Inc.
Radiological Software Device To Predict Future Breast Cancer Risk
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Voluson Performance 16; Voluson Performance 18
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
CoLumboX
Smart Soft Healthcare AD
MR image reconstruction/enhancement
TAIMedImg DeepMets
Taiwan Medical Imaging Co., Ltd.
RT auto-contouring
Rapid MLS
🇺🇸iSchemaView, Inc.
MR image reconstruction/enhancement
Accuro 3S
🇺🇸Rivanna Medical, Inc.
System, Imaging, Pulsed Echo, Ultrasonic
DEEPECHO
DeepEcho
System, Imaging, Pulsed Doppler, Ultrasonic
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
