(77 days)
The Model PXS-810 Podiatry X-Ray System is intended for General Purpose Podiatry Radiographic Applications.
Not Found
This document is an FDA 510(k) clearance letter for an X-ray System, Podiatry (Model PXS-810). It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for that specific information from this document. The letter focuses on the regulatory clearance process and substantial equivalence, not on the detailed technical data or clinical study results that would typically include such details.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.