(92 days)
The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
The PRECISION RXi System was originally cleared by the FDA under 510(k) K041605. This submission describes design changes including modifications to the positioner tilting/elevating movement and the compressor.
This document does not contain the specific information required to answer your request. The provided text is a 510(k) premarket notification for an X-ray system, focusing on its classification, indications for use, and design changes. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in evaluation.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and the study proving the device meets them based on the provided input.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.