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.
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
syngo.CT LVO Detection
🇺🇸Siemens Medical Solutions USA, Inc.
Triage & notification (CADt)
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
cmAngio® (V1.6)
🇺🇸CureMetrix, Inc.
MR image reconstruction/enhancement
BunkerHill BMD
🇺🇸BunkerHill Health
Densitometer, Bone
HeartFocus (V.1.1.1)
🇫🇷Deski
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
QFR (3.0)
🇳🇱QFR Solutions bv
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
DeepFoqus (DeepFoqus-Accelerate)
Foqus Technologies Inc.
MR image reconstruction/enhancement
syngo Dynamics (Version VA41D)
🇩🇪Siemens Healthcare GmbH
MR image reconstruction/enhancement
Hi-D Imaging 4TAVR
Hi-D Imaging AG
MR image reconstruction/enhancement
MR Contour DL
🇺🇸GE Healthcare
RT auto-contouring
TribusConnect
TribusMed Beheer BV
MR image reconstruction/enhancement
AI-Rad Companion Organs RT
🇩🇪Siemens Healthcare GmbH
RT auto-contouring
Salix Central
Artrya Limited
MR image reconstruction/enhancement
V5med Lung AI
V5med Inc.
Lung Computed Tomography System, Computer-Aided Detection
Rayvolve LN
🇺🇸AZmed
Analyzer, Medical Image
Rayvolve PTX-PE
🇺🇸AZmed
Lesion detection/diagnosis software
Vent Creativity Knee v1.0 (Hermes)
🇺🇸Vent Creativity
MR image reconstruction/enhancement
brAIn Shoulder Positioning
🇺🇸Avatar Medical
System, Image Processing, Radiological
AVIEW
🇰🇷Coreline Soft Co.,Ltd
MR image reconstruction/enhancement
PeekMed web
🇵🇹Peek Health, S.A.
MR image reconstruction/enhancement
