AI devices with FDA product code PIB — Diabetic Retinopathy Detection Device
Product code PIB (“Diabetic Retinopathy Detection Device” in openFDA) covers 7 devices on the FDA AI-enabled list, from 6 companies. Most are reviewed by the Ophthalmic panel (7). The most recent decision was AEYE-DS on April 23, 2024.
7AI devices
4Companies
2018First decision
2024-04-23Latest decision
Trend: devices per year
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