AI devices with FDA product code QQI — Interventional Cardiovascular Implant Simulation Software Device

Product code QQI (“Interventional Cardiovascular Implant Simulation Software Device” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Cardiovascular panel (1). The most recent decision was FEops HEARTguide Simulation Application on November 25, 2025.