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 Iray Technology Taicang , Ltd., Genoray Co., Ltd. and Ray Co., Ltd..
List of System, X-ray, Extraoral Source, Digital devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, X-ray, Extraoral Source, Digital devices (product code MUH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →