AI Devices

Cleared in 2017

Radiology AI devices with a 2017 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.

US

Radiomics App v1.0

🇺🇸Microsoft Corp.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

Infinitt PACS 7.0

🇰🇷Infinitt Healthcare Co.,Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

Quantra

🇺🇸Hologic, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

BladderScan Prime PLUS System

Verathon Incorporated

System, Imaging, Pulsed Echo, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2017
US

Clarius Ultrasound System

🇨🇦Clarius Mobile Health Corp.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2017
US

NeuroQuant

🇺🇸CorTechs Labs, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

QuantX

Quantitative Insights, Inc

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image managementDe Novo 2017
US

syngo Application Software

🇺🇸Siemens Medical Solutions USA, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

SmartTarget

SmartTarget, Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

UNiD Spine Analyzer

🇫🇷Medicrea International

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

Lung Vision

🇮🇱Body Vision Medical Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

AmCAD-UV

🇹🇼AmCad BioMed Corporation

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

PowerLook® Tomo Detection Software

🇺🇸iCAD, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image managementPMA 2017
US

SIS Software

Surgical Information Sciences, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

Quantib Brain 1.2

🇳🇱Quantib BV

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017
US

Arterys Cardio DL

🇺🇸Arterys, Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2017