(56 days)
The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a letter from the FDA to Eastman Kodak Company regarding the 510(k) premarket notification for "Kodak Eclipse Image processing software," confirming its substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request for information about acceptance criteria and study details based on the given input.
§ 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.