(78 days)
General Radiography as prescribed by competent authority.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets them. The text is a 510(k) clearance letter from the FDA for the IMIX Thorax, Vertical X-Ray Imaging System and pertains to the substantial equivalence determination for market authorization. It does not include performance metrics, study design details, or expert qualifications.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.