FDA Radiology AI Devices

HealthCCSng is a software device that automatically analyzes non-cardiac-gated CT scans to estimate the amount of calcified plaque in coronary arteries, which can indicate coronary artery disease risk. It provides radiologists with calcium detection categories and annotated images to aid in clinical decision-making within their usual workflow.

HealthCCS is a software tool that uses cardiac CT images to automatically identify and measure calcified plaques in the coronary arteries. This helps physicians assess coronary artery disease risk by providing a calcium score and risk category report based on pre-existing CT scans, aiding further clinical decisions and patient management.