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., Qpix Solutions, Inc. and Genoray Co., Ltd..
FDA 510(k) Cleared System, X-ray, Extraoral Source, Digital Devices (Product Code MUH)
About Product Code MUH - Regulatory Context
510(k) Submission Activity
206 total 510(k) submissions under product code MUH since 1998, with 206 receiving FDA clearance (average review time: 101 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
Recent submissions under MUH have taken an average of 156 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
MUH devices are reviewed by the Radiology panel. Browse all Radiology devices →