FDA Radiology AI Devices

HeartFlow FFRct is a software tool that analyzes existing CT images of coronary arteries to calculate fractional flow reserve (FFRCT). This helps clinicians assess the functional significance of coronary artery disease non-invasively, aiding diagnosis and treatment decisions without requiring additional imaging or radiation.

The Imbio CT Lung Density Analysis Software assists physicians by automatically processing CT scans of the lungs to quantify lung tissue density and identify abnormalities. It provides tools for 3D segmentation, volumetric analysis, and reporting, helping in diagnosis and monitoring of pulmonary conditions.

CVI42 is a software tool designed for analyzing CT and MR images of blood vessels. It provides tools for image visualization, processing, vessel centerline and lumen calculations, stenosis evaluation, and lesion characterization. This helps physicians evaluate and track vascular lesions more effectively for improved patient diagnosis and management.

Hepatic VCAR is a software tool that analyzes CT scans of the liver to help clinicians visualize liver anatomy, detect and measure liver lesions, and assess liver morphology. It provides initial 3D segmentation and vessel analysis with tools allowing users to adjust and confirm segmentation, assisting in clinical review, archiving, and diagnosis related to liver conditions.

AlphaPoint Imaging Software is a tool that helps clinicians review and analyze CT chest images by providing segmentation and numerical analysis of tissue types. It assists in identifying different substances in the images and generates preliminary reports to support medical decision-making.