AI devices with FDA product code QHA — X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Product code QHA (“X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Radiology panel (2). The most recent decision was X1-FFR on October 17, 2025.