(71 days)
- The device is a Surgical Mobile C-arm Imaging X-ray System and allows a technician to examine a patient by fluoroscopy or radiography.
- This device is operated and used by Physicians and X-ray technologist.
- The object of this device is total patient populations.
The device is a Surgical Mobile C-arm Imaging X-ray System.
This is a 510(k) premarket notification for a Shimadzu Corporation Surgical Mobile C-arm Imaging X-ray System, model WHA-200. This document is an FDA communication regarding substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the provided text.
§ 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.