(158 days)
The BELRAY II, Model 097 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor.
extraoral source dental radiographic x-ray unit
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental x-ray unit, which outlines its regulatory classification, indications for use, and compliance requirements. It does not include details about device performance tests, acceptance criteria, study methodologies, or expert reviews as you've requested.
§ 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.