AI Devices

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.

EmergencyUS

BriefCase

🇮🇱Aidoc Medical , Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2020
US

AI Metrics

AI Metrics, LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

EchoGo Pro

🇬🇧Ultromics Ltd

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2020
US

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

Deep Learning Image Reconstruction for Gemstone Spectral Imaging

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

HepaFat-AI

🇦🇺Resonance Health Analysis Services Pty Ltd

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2020
US

HealthJOINT

Zebra Medical Vision Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

Revolution Ascend

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

CorInsights MRI

ADM Diagnostics, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
EmergencyUS

HALO

🇳🇱NICo-Lab B.V.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2020
BreastUS

Genius AI Detection

🇺🇸Hologic, Inc.

Breast CAD (tomosynthesis)

Mammo / DBTDetection (CADe)510(k) 2020
US

syngo.via MI Workflows, syngo MBF

🇺🇸Siemens Medical Solutions USA, Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2020
US

PROView

🇫🇷GE Medical Systems SCS

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

FastStroke, CT Perfusion 4D

🇫🇷GE Medical Systems SCS

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2020
US

AI-Rad Companion Organs RT

🇺🇸Siemens Medical Solutions USA, Inc.

RT auto-contouring

CTSegmentation510(k) 2020
US

Neuro.Al Algorithm

🇺🇸Terarecon,Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

WRDensity by Whiterabbit.ai

Whiterabbit.ai Inc.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2020
US

AutoContour

🇺🇸Radformation, Inc.

RT auto-contouring

CTSegmentation510(k) 2020
US

A View LCS

🇰🇷Coreline Soft Co.,Ltd

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

SIGNA 7.0T

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2020
US

Quantib Prostate

🇳🇱Quantib BV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

Cleerly Labs v2.0

🇺🇸Cleerly, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

LiverMultiScan

🇬🇧Perspectum, Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2020
US

THINQ

CorticoMetrics LLC

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

LVivo Seamless

DiA Imaging Analysis Ltd.

MR image reconstruction/enhancement

MRReconstruction & enhancement510(k) 2020
US

Xeleris V Processing and Review Systems

🇺🇸GE Healthcare

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

RayStation

🇸🇪RaySearch Laboratories AB (PUBL)

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2020
US

Caption Guidance

Caption Health

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Multi-modalityWorkflow & image management510(k) 2020
US

EchoPAC Software Only, EchoPAC Plug-In

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
US

AVA (Augmented Vascular Analysis)

See-Mode Technologies Pte. Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2020
Page 1 of 4Older