(83 days)
The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.
The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.
The provided text is a 510(k) K992603 clearance letter for the Wuestec XRT 600 R/F device, along with its "Indications For Use" statement.
This documentation does not contain any information regarding acceptance criteria, device performance metrics, or study design details. It is a regulatory approval document that states the device has been found substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given input.
To answer your request, I would need a document such as:
- A premarket submission summary.
- A clinical study report.
- A scientific publication detailing the device's performance evaluation.
The current document only confirms the FDA's regulatory clearance for the device, not the technical or clinical performance data.
§ 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.