AI devices with FDA product code SAX — Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Product code SAX (“Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Ophthalmic panel (1). The most recent decision was Notal Vision Home Optical Coherence Tomography (OCT) System on May 15, 2024.