(28 days)
The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography
The provided document is a 510(k) clearance letter for the Carestream DRX-Evolution, a stationary x-ray system. It does not contain any information regarding acceptance criteria, device performance, or any studies conducted on the device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and general information required for marketing the device.
§ 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.