(30 days)
Radiaction's Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided-procedures with the Toshiba Infinix-I or Siemens Artis C-arm, by attenuation. It is not intended to be used with such procedures for head and neck areas.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the "Shield System" (K222625) by Radiaction Ltd. does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any detailed study methodology. The letter primarily focuses on the FDA's decision regarding substantial equivalence, regulatory compliance, and general information about medical device regulations.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The provided document is a regulatory clearance letter, not a device performance 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.