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.
Neurophet AQUA (V3.1)
🇰🇷Neurophet., Inc.
MR image reconstruction/enhancement
nordicMEDiVA
🇳🇴NordicNeurolab AS
System, Image Processing, Radiological
Contour+ (MVision AI Segmentation)
🇫🇮Mvision AI Oy
RT auto-contouring
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
SIGNA MAGNUS
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
cvi42 Software Application
🇨🇦Circle Cardiovascular Imaging, Inc.
MR image reconstruction/enhancement
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
EchoMeasure
iCardio.ai
MR image reconstruction/enhancement
Limbus Contour
Limbus AI Inc.
RT auto-contouring
EPIQ Series Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
SpineUs System
🇺🇸Verdure Imaging
System, Imaging, Pulsed Echo, Ultrasonic
Lunit INSIGHT DBT v1.1
🇰🇷Lunit, Inc.
Breast CAD (tomosynthesis)
EchoSolv AS
Echo IQ Ltd
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
LVivo Software Application
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
Versana Premier; Versana Premier Lotus; LOGIQ F
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
MammoScreen BD
🇺🇸Therapixel
MR image reconstruction/enhancement
LungVision
BodyVision Medical Ltd.
MR image reconstruction/enhancement
MuscleView
Springbok, Inc.
System, Nuclear Magnetic Resonance Imaging
CAC (gated) Algorithm
🇺🇸BunkerHill Health
System, X-Ray, Tomography, Computed
JBS-LVO
🇰🇷JLK, Inc.
Triage & notification (CADt)
uAI Easy Triage ICH
Shanghai United Imaging Intelligence Co., Ltd.
Triage & notification (CADt)
MAMMOMAT B.brilliant with Tomosynthesis Option
🇺🇸Siemens Medical Solutions USA, Inc.
Digital Breast Tomosynthesis
PIUR tUS Infinity
🇦🇹PIUR Imaging GmbH
MR image reconstruction/enhancement
Constellation (CON-001)
Q Bio, Inc.
MR image reconstruction/enhancement
CINA-CSpine
🇫🇷Avicenna.AI
Triage & notification (CADt)
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
🇯🇵Canon Medical Systems Corporation
System, Imaging, Pulsed Doppler, Ultrasonic
FETOLY-HEART
🇫🇷Diagnoly
System, Imaging, Pulsed Doppler, Ultrasonic
LumiNE US; Lumi
Augmedit B.V.
MR image reconstruction/enhancement
ADAS 3D
🇪🇸Adas3D Medical S.L
MR image reconstruction/enhancement
Overjet Image Enhancement Assist
Overjet, Inc.
MR image reconstruction/enhancement
