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.
Automatic Anatomy Recognition (AAR)
Quantitative Radiology Solutions, LLC
RT auto-contouring
AI Segmentation
🇺🇸Varian Medical Systems, Inc.
System, Planning, Radiation Therapy Treatment
Saige-Q
DeepHealth, Inc.
Lesion detection/diagnosis software
BriefCase, RIB Fractures Triage (RibFx)
🇮🇱Aidoc Medical , Ltd.
Lesion detection/diagnosis software
DV. Target
Deepvoxel INC
RT auto-contouring
Eclipse II with Smart Noise Cancellation
🇺🇸Carestream Health, Inc.
Solid State X-Ray Imager (Flat Panel/Digital Imager)
SIS System (Version 5.1.0)
Surgical Information Sciences, Inc.
System, Image Processing, Radiological
syngo.CT Lung CAD
🇩🇪Siemens Healthcare GmbH
Lung Computed Tomography System, Computer-Aided Detection
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Viz ICH
🇺🇸Viz.ai, Inc.
Triage & notification (CADt)
VBrain
Vysioneer Inc.
RT auto-contouring
Oncospace
Oncospace, Inc.
System, Planning, Radiation Therapy Treatment
ProFound AI Software V3.0
🇺🇸iCAD, Inc.
Breast CAD (tomosynthesis)
Imbio RV/LV Software
Imbio, LLC
MR image reconstruction/enhancement
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
🇬🇧Optellum Ltd
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
MaxFOV 2
🇺🇸Ge Medical Systems, LLC
System, X-Ray, Tomography, Computed
SubtleMR
🇺🇸Subtle Medical, Inc.
System, Image Processing, Radiological
NinesMeasure
Nines, Inc.
System, Image Processing, Radiological
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
🇨🇦Perimeter Medical Imaging AI, Inc.
System, Imaging, Optical Coherence Tomography (Oct)
TruPlan
🇨🇦Circle Cardiovascular Imaging, Inc.
System, Image Processing, Radiological
Synapse 3D, Synapse 3D Base Tools v6.1
🇯🇵Fujifilm Corporation
System, Image Processing, Radiological
LVivo Software Application
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
QUIBIM Precision Prostate (qp-Prostate)
🇪🇸Quibim S.L.
System, Image Processing, Radiological
Visage Breast Density
🇩🇪Visage Imaging GmbH
MR image reconstruction/enhancement
Vantage Orian 1.5T, MRT-1550, V6.0
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
uAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.
Lesion detection/diagnosis software
ART-Plan
🇫🇷TheraPanacea
RT auto-contouring
Hepatica v1 (Hepatica v1.0.0)
🇬🇧Perspectum, Ltd.
System, Nuclear Magnetic Resonance Imaging
