AI devices with FDA product code OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Product code OUO (“Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Radiology panel (2). The most recent decision was BIOGRAPH One on January 15, 2026.