AI devices with FDA product code SHP — Cardiac Amyloidosis Machine Learning-Based Notification Software

Product code SHP (“Cardiac Amyloidosis 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 ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) on April 7, 2026.