(29 days)
The ARCADIS Avantic is a mobile x-ray system which can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Digital Cine Mode (DCM), Subtraction, and Roadmapping, which are necessary to perform a wide variety of clinical procedures. Clinical applications may include, but are not limited to, card/vascular, gastroenterology, electrophysiology, urologic, orthopedic, neurologic, pediatrics, endoscopy, pain therapy and emergency room procedures
The ARCADIS Avantic is an x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, TV camera, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitor(s), and user interface. The system is equipped with a footswitch and a hand switch for radiation release.
The provided text is a 510(k) summary for a mobile X-ray system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on the results of a detailed performance study against specific acceptance criteria.
§ 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.