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.
Ultrasound Workspace (UWS 6.0)
🇺🇸Philips Ultrasound, LLC
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
BoneMetrics (US)
Gleamer SAS
MR image reconstruction/enhancement
Contour ProtégéAI+
🇺🇸Mim Software, Inc.
RT auto-contouring
Bunkerhill AVC
🇺🇸BunkerHill Health
System, X-Ray, Tomography, Computed
TeraRecon Aorta.CT (1.1.0)
🇺🇸Terarecon,Inc.
MR image reconstruction/enhancement
Rapid Neuro3D
🇺🇸iSchemaView, Inc.
MR image reconstruction/enhancement
Prenuvo Body Composition
🇺🇸Prenuvo
System, Nuclear Magnetic Resonance Imaging
TechCare Trauma
🇫🇷Milvue
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
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
Aquilion ONE (TSX-308A/3) V1.5
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Lightning Viewer
Nexsys Electronics Inc. dba Medweb
System, Image Processing, Radiological
Saige-Density (2.5.0)
DeepHealth, Inc.
MR image reconstruction/enhancement
OrthoNext Platform System
🇮🇹Orthofix Srl
MR image reconstruction/enhancement
IQ-UIP
Imbio, Inc.
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Saige-Dx (3.1.0)
DeepHealth, Inc.
Breast CAD (tomosynthesis)
