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.
CT CoPilot
ZEPMED, LLC.
System, Image Processing, Radiological
Clarius Ultrasound System
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
QVCAD System
🇺🇸QView Medical, Inc.
Analyzer, Medical Image
PixelShine
ALGOMEDICA
System, Image Processing, Radiological
ClearRead CT
RIVERAIN TECHNOLOGIES, LLC
Lung Computed Tomography System, Computer-Aided Detection
icobrain
🇧🇪icometrix
System, Image Processing, Radiological
LVivo Software Application
DIACARDIO, LTD.
System, Image Processing, Radiological
Cydar EV
🇬🇧Cydar Ltd.
Interventional Fluoroscopic X-Ray System
Quantib Brain 1
🇳🇱Quantib BV
System, Image Processing, Radiological
Volpara Imaging Software
Matakina Technology LTD
System, Image Processing, Radiological
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
System, Image Management, Ophthalmic
QUANTRA
🇺🇸Hologic, Inc.
System, Image Processing, Radiological
Lung Density Analysis
Imbio, LLC
System, X-Ray, Tomography, Computed
CVI42
🇨🇦Circle Cardiovascular Imaging, Inc.
System, Image Processing, Radiological
HEPATIC VCAR
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
YSIO MAX
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Stationary
CLEARREAD +CONFIRM
🇺🇸RIVERAIN TECHNOLOGIES
System, Image Processing, Radiological
ALPHAPOINT IMAGING SOFTWARE
RADLogics, Inc.
System, Image Processing, Radiological
DELTAVIEW MODEL 2.1
RIVERAIN MEDICAL GROUP,LLC
System, Image Processing, Radiological
QUANTRA
🇺🇸Hologic, Inc.
System, Image Processing, Radiological
IB NEURO, VERSION 1.0
🇺🇸IMAGING BIOMETRICS, LLC
System, Nuclear Magnetic Resonance Imaging
SECOND LOOK ™
🇺🇸iCAD, Inc.
Analyzer, Medical Image
RAPIDSCREEN RS-2000
RIVERAIN MEDICAL GROUP
Analyzer, Medical Image
LOGICON CARIES DETECTOR
🇺🇸CARESTREAM DENTAL LLC
Analyzer, Medical Image
M1000 IMAGECHECKER
🇺🇸Hologic, Inc.
Analyzer, Medical Image
