AI devices with FDA product code SHL — Ear, Nose, And Throat Image Analyzer

Product code SHL (“Ear, Nose, And Throat Image Analyzer” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Ear Nose & Throat panel (1). The most recent decision was Tyto Insights for Eardrum Bulging Detection on March 17, 2026.