(203 days)
The MECALL CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.
The device is intended for use in:
- Skeleton
- Chest and lungs
- Pediatrics
- Emergency/traumatology
- Gastroenterology
- Urology and gynecology
- Linear tomography
- Digital angiography
- Stitching
Not Found
The provided document is a 510(k) summary for a fluoroscopic x-ray system, the MECALL CLISIS SYSTEMS, Discovery RF180. It states the indications for use but does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, expert adjudication, or sample sizes for training or testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about any of the other requested study details based on this document. This document is a regulatory clearance letter, not a detailed study report.
§ 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.