FDA Radiology AI Devices

HeartFlow Analysis is a medical software that uses previously acquired coronary CT images to create 3D models and simulate blood flow dynamics in coronary arteries. It helps clinicians assess coronary artery disease by providing detailed functional information derived mathematically from CT scans, supporting diagnosis and treatment planning in stable symptomatic patients.

The FFRangio System is a software tool that analyzes previously acquired angiographic images using 3D computer modeling to simulate blood flow in coronary arteries. It provides a mathematically derived value to support the functional assessment of coronary artery disease, helping clinicians evaluate artery physiology and make informed treatment decisions.

FFRct by HeartFlow, Inc. is software that analyzes previously acquired coronary CT images to simulate blood flow and pressure in the coronary arteries. It helps clinicians evaluate coronary artery disease by providing a computer-generated physiological assessment using AI-driven computational models from static CT data.

HeartFlow FFRct is a software tool that analyzes previously acquired coronary CT images to simulate coronary blood flow and pressure, aiding clinicians in evaluating coronary artery disease without additional invasive procedures. It provides functional assessment by generating fractional flow reserve values to support clinical decision-making alongside other diagnostic information.