AI devices with FDA product code PBH — Embryo Image Assessment System, Assisted Reproduction

Product code PBH (“Embryo Image Assessment System, Assisted Reproduction” in openFDA) covers 3 devices on the FDA AI-enabled list, from 3 companies. Most are reviewed by the Obstetrics and Gynecology panel (3). The most recent decision was Embryo Predict on May 15, 2026.