(204 days)
This 3-D X-ray system, aka CBCT (cone beam computed tomography) is used to perform radiographic examination of the oral and maxillofacial structure. It is intended to be used in both radiology centers and average-large dental offices, specialized in implantology.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the MyRay SkyView device. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. It also includes an "Indication for Use" statement for the device.
Based on the provided text, the document does not report on acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed information requested in the prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC study results).
The document is a regulatory approval letter, indicating that the device has received market clearance based on a determination of substantial equivalence to a predicate device. It does not contain the technical details of device performance studies.
Therefore, I cannot provide the requested information from this document.
§ 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.