Cleared in 2020
Radiology AI devices with a 2020 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
Vivid iq
🇺🇸GE Medical Systems Ultrasound and
System, Imaging, Pulsed Doppler, Ultrasonic
Vivid T8, Vivid T9
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
SIGNA Artist
🇨🇳GE Healthcare (Tianjin) Company Limited
System, Nuclear Magnetic Resonance Imaging
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
AVIEW
🇰🇷Coreline Soft Co.,Ltd
System, Image Processing, Radiological
TOMTEC-ARENA
🇩🇪TOMTEC Imaging Systems GmbH
System, Image Processing, Radiological
Syngo.via RT Image Suite
🇺🇸Siemens Medical Solutions USA, Inc.
System, Planning, Radiation Therapy Treatment
Limbus Contour
Limbus AI Inc.
System, Image Processing, Radiological
VIDAvision
VIDA Diagnostics Inc.
System, X-Ray, Tomography, Computed
Accipiolx
MaxQ Al Ltd.
Triage & notification (CADt)
HYPER DLR
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
FractureDetect (FX)
🇺🇸Imagen Technologies, Inc
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
AI-Rad Companion Prostate MR
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
Vivid E80/ Vivid E90/ Vivid E95
🇺🇸GE Medical Systems Ultrasound and
System, Imaging, Pulsed Doppler, Ultrasonic
Caption Interpretation Automated Ejection Fraction Software
Caption Health
MR image reconstruction/enhancement
Vivid S60N, Vivid S70N
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
HealthMammo
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
AI-Rad Companion Engine
🇺🇸Siemens Medical Solutions USA, Inc.
System, Image Processing, Radiological
Ezra Plexo Software
🇺🇸Ezra AI, Inc.
MR image reconstruction/enhancement
Rapid LVO
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
Deep Recon
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
Contour ProtegeAI
🇺🇸Mim Software, Inc.
RT auto-contouring
InferRead Lung CT.AI
Beijing Infervision Technology Co.,Ltd.
Lung Computed Tomography System, Computer-Aided Detection
Rapid ASPECTS
🇺🇸iSchemaView, Inc.
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
CINA
🇫🇷Avicenna.AI
Triage & notification (CADt)
LVivo Software Application
DiA Imaging Analysis Ltd.
MR image reconstruction/enhancement
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
qER
🇮🇳Qure.Ai Technologies
Triage & notification (CADt)
AI-Rad Companion Brain MR
🇺🇸Siemens Medical Solutions USA, Inc.
System, Image Processing, Radiological
