(394 days)
The Model PXS-710D X-Ray System is intended for General Purpose Podiatry Radiographic Applications.
Not Found
This 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria for the Podiatry X-Ray System (Model PXS-710D).
The provided text is a standard FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms the device's substantial equivalence to predicate devices but does not include clinical study data, performance metrics, ground truth establishment, or sample sizes related to the device's specific performance.
Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory clearance, not on the technical performance study 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.