FDA Product Code MUH: System, X-ray, Extraoral Source, Digital

FDA product code MUH covers digital extraoral dental X-ray systems used for panoramic and cephalometric imaging.

These systems use a rotating X-ray source and digital sensor to capture wide-field images of the entire dentition, jaws, and surrounding structures in a single exposure. They are the standard imaging modality for orthodontic assessment, implant planning, and evaluation of jaw pathology.

MUH devices are Class II medical devices, regulated under 21 CFR 872.1800 and reviewed by the FDA Radiology panel.

Leading manufacturers include VATECH Co., Ltd., Sirona Dental Systems GmbH and Rayence Co., Ltd..