(106 days)
The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.
The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.
This document is a 510(k) clearance letter from the FDA for a dental X-ray generator, the "Dental X-Ray Z70." It discusses regulatory aspects but does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from the provided text.
The letter explicitly states that the FDA's "substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It is primarily a regulatory clearance and not a detailed study report.
§ 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.