Cleared in 2019
Radiology AI devices with a 2019 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
QLAB Advanced Quantification Software
🇨🇳Philips Healthcare
MR image reconstruction/enhancement
syngo.CT CaScoring
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
QyScore Software
🇫🇷Qynapse
System, Image Processing, Radiological
Deep Learning Image Reconstruction
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
Icobrain
icometrix NV
System, Image Processing, Radiological
NemoScan
🇪🇸Software Nemotec S.L.
System, Image Processing, Radiological
Transpara
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
PhantomMSK Trauma
🇺🇸OrthoGrid Systems Inc.
System, Image Processing, Radiological
HealthCXR
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
RSI-MRI+
MultiModal Imaging Services Corporation (dba HealthLytix)
System, Image Processing, Radiological
EchoGo Core
🇬🇧Ultromics Ltd
MR image reconstruction/enhancement
MEDIP PRO
MEDICALIP Co., Ltd
System, Image Processing, Radiological
Cleerly Labs
🇺🇸Cleerly, Inc.
System, Image Processing, Radiological
KOALA
🇫🇷IB Lab GmbH
System, Image Processing, Radiological
RTHawk, HeartVista Cardiac Package
HeartVista, Inc.
System, Nuclear Magnetic Resonance Imaging
Merge PACS
🇺🇸Merge Healthcare Incorporated
System, Image Processing, Radiological
Ventripoint Medical System Plus (VMS+) 3.0
🇨🇦Ventripoint Diagnostics Ltd.
System, Image Processing, Radiological
ProFound AI Software V2.1
🇺🇸iCAD, Inc.
Breast CAD (tomosynthesis)
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
🇺🇸Omega Medical Imaging, LLC
System, X-Ray, Fluoroscopic, Image-Intensified
Syngo.Via RT Image Suite
🇺🇸Siemens Medical Solutions USA, Inc.
System, Planning, Radiation Therapy Treatment
SubtleMR
🇺🇸Subtle Medical, Inc.
System, Image Processing, Radiological
SIS Software Version 3.6.0
Surgical Information Sciences, Inc.
System, Image Processing, Radiological
AI-Rad Companion (Cardiovascular)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
