(383 days)
ARCO FP is a mobile x-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. Arco FP device can be used on all patients except pediatric patients within the limits of the device.
ARCO FP is a mobile x-ray device.
This document is a 510(k) clearance letter for a medical device (ARCO FP) and contains no information about acceptance criteria or a study proving that acceptance criteria are met. The document focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device.
§ 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.