(51 days)
The Orthophos 5/PLUS/CD is an extraoral X-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging, teleradiography, and transverse slice imaging.
The Orthophos 5/PLUS/CD is an extraoral X-ray system.
This document is a marketing clearance letter from the FDA for the Orthophos 5/PLUS/CD X-ray system. It does not contain any information about acceptance criteria or a study proving device performance. Therefore, I cannot generate the requested information based on the provided text.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.