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.
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
BoneView
🇨🇳Gleamer
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Rapid NCCT Stroke
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
Xeleris V Processing and Review System
🇺🇸GE Healthcare
System, Image Processing, Radiological
Caption Interpretation Automated Ejection Fraction Software
Caption Health, Inc.
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
AVIEW Lung Nodule CAD
🇰🇷Coreline Soft Co.,Ltd
Lung Computed Tomography System, Computer-Aided Detection
Brainomix 360 e-ASPECTS
🇬🇧Brainomix Limited
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
BoneMRI v1.6
🇳🇱MRIguidance B.V
MR image reconstruction/enhancement
Swoop® Portable MR Imaging System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
uMR 680
Shanghai United Imaging Intelligence Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
SIGNA Victor
🇨🇳GE Healthcare (Tianjin) Company Limited
System, Nuclear Magnetic Resonance Imaging
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Videa Perio Assist
🇺🇸VideaHealth Inc.
MR image reconstruction/enhancement
Oncospace
Oncospace, Inc.
System, Planning, Radiation Therapy Treatment
LVivo IQS
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
Rapid RV/LV
iSchema View Inc.
MR image reconstruction/enhancement
BriefCase
🇮🇱Aidoc Medical , Ltd.
Lesion detection/diagnosis software
QOCA image Smart CXR Image Processing System
🇹🇼Quanta Computer Inc.
Lesion detection/diagnosis software
Clarius AI
🇨🇦Clarius Mobile Health Corp.
MR image reconstruction/enhancement
TruPlan Computed Tomography (CT) Imaging Software
🇨🇦Circle Cardiovascular Imaging, Inc.
System, Image Processing, Radiological
MR Diffusion Perfusion Mismatch V1.0
🇫🇷Olea Medical
System, Image Processing, Radiological
AIBOLIT 3D+
Aibolit Technologies, LLC
System, Image Processing, Radiological
AVIEW
🇰🇷Coreline Soft Co.,Ltd
MR image reconstruction/enhancement
MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands B.V.
System, Nuclear Magnetic Resonance Imaging
Philips CT 3500
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
Overjet Calculus Assist
Overjet, Inc.
Analyzer, Medical Image
BrainInsight
🇺🇸Hyperfine, Inc.
MR image reconstruction/enhancement
Saige-Density
DeepHealth, Inc.
MR image reconstruction/enhancement
