(57 days)
The Cardiac Mariners, Inc. VASCO scanning beam digital x-ray System is THE Ourdlations, mor in generating real time fluoroscopic images in patients where medically indicated.
VASCO SYSTEM
The provided text is a 510(k) clearance letter and a Statement of Intended Use for the "Vasco Scanning Beam" digital x-ray system. This document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.
Therefore, I cannot fulfill the request to describe the 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.