FDA Radiology AI Devices

Marie is a computed tomography (CT) X-Ray system designed to capture detailed cross-sectional images of the body, aiding clinicians in diagnosing and monitoring various medical conditions through advanced imaging techniques.

ClearRead CT CAC is software that helps physicians assess coronary artery calcification on non-contrast, non-gated chest CT scans. It automatically detects and quantifies calcified coronary lesions, providing an Agatston score and categorization to aid in cardiovascular risk assessment. This allows clinicians to efficiently obtain quantitative calcium scoring to help guide patient management, supplementing but not replacing clinical expert review.

BriefCase-Quantification by Aidoc Medical is an AI-driven software designed to analyze non-cardiac-gated, non-contrast CT scans including the heart to detect and categorize coronary artery calcification (CAC). It provides physicians with a four-category risk assessment for coronary artery disease along with preview images of detected calcium, assisting clinical evaluation but not replacing full image review or clinical judgement.

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.