(15 days)
The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used.
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This document is a 510(k) clearance letter from the FDA for the Kodak DirectView DR System Detector. It does not contain information about acceptance criteria or specific study details to prove the device meets those criteria.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing performance data from a specific study.
§ 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.