AI devices with FDA product code OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile

Product code OXO (“Image-Intensified Fluoroscopic X-Ray System, Mobile” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Radiology panel (1). The most recent decision was OEC One CFD on November 26, 2025.