FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The Cardiac CT Function Software Application by Circle Cardiovascular Imaging is a software tool that assists medical professionals in analyzing cardiac function from multi-phase, multi-slice cardiovascular CT angiography images. It uses AI to segment cardiac structures and compute key function metrics such as volume and ejection fraction, helping clinicians evaluate heart function more accurately and efficiently.

FDA #
K241038
Product Code
QIH

cvi42 Auto Imaging Software Application is an AI-powered medical imaging software designed to assist clinicians in evaluating cardiovascular MR and CT images. It uses machine learning to semi-automatically contour cardiac structures, perform calcium scoring, and analyze coronary arteries, aiding in diagnosis and quantitative assessment of heart and vessel conditions.

FDA #
K213998
Product Code
QIH
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