AI devices with FDA product code IYE — Accelerator, Linear, Medical

Product code IYE (“Accelerator, Linear, Medical” in openFDA) covers 3 devices on the FDA AI-enabled list, from 3 companies. Most are reviewed by the Radiology panel (3). The most recent decision was EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) on January 15, 2026.