(88 days)
The TROPHYPAN Panoramic Dental X-Ray System is to be used as an external source of X-ray for imaging of the dento-maxillo-facial area and provides digital radiographic images only through the built-in DIGIPAN ( K012514), digital imaging system.
TROPHYPAN Panoramic Dental X-Ray System
This document is an FDA 510(k) clearance letter for the TrophyPan Panoramic Dental X-Ray System. It does not contain the acceptance criteria or a study proving the device meets those criteria. Instead, it states that the device is substantially equivalent to a legally marketed predicate device for its indicated use.
Therefore, I cannot provide the requested information based on this document. The document primarily focuses on regulatory approval and classification rather than detailed performance study results.
§ 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.