(88 days)
The Symphony 200 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Symphony 9090 Remote Control Table." This document primarily addresses the FDA's determination of substantial equivalence and does not contain detailed information about acceptance criteria, device performance studies, or ground truth establishment.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a study report or technical specification detailing performance metrics.
§ 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.