Product code

AI devices with FDA product code QYE — Reduced Ejection Fraction Machine Learning-Based Notification Software

Product code QYE (“Reduced Ejection Fraction Machine Learning-Based Notification Software” in openFDA) covers 5 devices on the FDA AI-enabled list, from 4 companies. Most are reviewed by the Cardiovascular panel (5). The most recent decision was Bunkerhill ECG-EF on September 19, 2025.

5AI devices
4Companies
2023First decision
2025-09-19Latest decision

Trend: devices per year

2023: 12024: 12025: 3
202320242025
AI devices with FDA product code QYE — Reduced Ejection Fraction Machine Learning-Based Notification Software per year: 2023 1, 2024 1, 2025 3

Top companies

All 5 devices, newest first