(56 days)
QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The QuickRayPRO shall be operated by healthcare professionals , who are educated and competent to perform the acquisition of dental intra-oral radiographs. The QuickRayPRO can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.
QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images.
I am sorry, but the provided text does not contain information on acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the QuickRayPRO device, which is a dental intra-oral radiology image acquisition system, and primarily discusses regulatory aspects and indications for use. Therefore, I cannot generate the requested table and information.
§ 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.