Cleared in 2021
Radiology AI devices with a 2021 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
Deep Learning Image Reconstruction
🇯🇵Ge Healthcare Japan Corporation
System, X-Ray, Tomography, Computed
Intelligent NR
🇯🇵Canon Inc.
Solid State X-Ray Imager (Flat Panel/Digital Imager)
HealthCCSng
Zebra Medical Vision Ltd.
System, X-Ray, Tomography, Computed
ClariSIGMAM
🇰🇷ClariPi Inc.
MR image reconstruction/enhancement
Versana Premier
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Aquilion Exceed LB
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
HERA W9, HERA W10 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
V8 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
AmCAD-UT
🇹🇼AmCad BioMed Corporation
MR image reconstruction/enhancement
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
🇩🇪Philips Medical Systems
System, Imaging, Pulsed Doppler, Ultrasonic
RayStation 11.0
🇸🇪RaySearch Laboratories AB (PUBL)
System, Planning, Radiation Therapy Treatment
AI Segmentation
🇺🇸Varian Medical Systems, Inc.
System, Planning, Radiation Therapy Treatment
Auto Lung Nodule Detection
🇰🇷Samsung Electronics Co.,Ltd.
Analyzer, Medical Image
EndoNaut
Therenva SAS
Interventional Fluoroscopic X-Ray System
RBknee
🇩🇰Radiobotics ApS
System, Image Processing, Radiological
Discovery MI Gen2
🇺🇸Ge Medical Systems, LLC
System, Tomography, Computed, Emission
TruSPECT Radiological Image Processing Station
🇮🇱Spectrum Dynamics Medical, Ltd.
System, Image Processing, Radiological
InferRead CT Stroke.AI
🇨🇳Infervision Medical Technology Co., Ltd.
Triage & notification (CADt)
uCT ATLAS with uWS-CT-Dual Energy Analysis
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
Vereos PET/CT
🇳🇱Philips Medical Systems Nederland B.V.
System, Tomography, Computed, Emission
Kosmos
🇺🇸EchoNous, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
breastscape v1.0
🇫🇷Olea Medical
MR image reconstruction/enhancement
qER-Quant
🇮🇳Qure.Ai Technologies
MR image reconstruction/enhancement
syngo.via RT Image Suite
🇺🇸Siemens Medical Solutions USA, Inc.
System, Planning, Radiation Therapy Treatment
aPROMISE
🇸🇪EXINI Diagnostics AB
System, Image Processing, Radiological
ClariCT.AI
🇰🇷ClariPi Inc.
System, Image Processing, Radiological
Volpara Imaging Software
Volpara Health Technologies Limited
System, Image Processing, Radiological
Us2.v1
Eko.ai Pte. Ltd d/b/a Us2.ai
MR image reconstruction/enhancement
Chest-CAD
🇺🇸Imagen Technologies, Inc
Analyzer, Medical Image
Change Healthcare Anatomical AI
🇨🇦Change Healthcare Canada Company
MR image reconstruction/enhancement
