FDA Product Code EHD: Unit, X-ray, Extraoral With Timer
Under FDA product code EHD, extraoral dental X-ray units with timers are cleared for panoramic and cephalometric radiography in dental practice.
These systems capture wide-field dental images of the jaws, teeth, and craniofacial structures from an external X-ray source positioned outside the mouth. Integrated timers control radiation exposure duration for consistent, reproducible image quality.
EHD 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., VATECH Co., Ltd. and Osstem Implant Co., Ltd..
List of Unit, X-ray, Extraoral With Timer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Unit, X-ray, Extraoral With Timer devices (product code EHD). 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 →