(132 days)
The MCA-601, C-Arm Mobile is used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images in real time without the need to develop individual films.
High frequency X-ray generator and Image intensifier systems are mounted on C-arm transport mobile base.
The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for a C-Arm Mobile Fluoroscopic System, indicating a name change for an existing device and its intended use. It largely comprises administrative details, such as company information, device classification, and a letter from the FDA confirming substantial equivalence to legally marketed predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance 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.