AI devices with FDA product code SBQ — Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Product code SBQ (“Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software” 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 Tempus ECG-AF on June 21, 2024.