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.

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.

FDA #
K182035
Product Code
PJA

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.

FDA #
K161772
Product Code
PJA
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