(29 days)
The KODAK DirectView DR 3000 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Not Found
The provided text describes a 510(k) premarket notification for the Kodak DirectView DR 3000 System, a stationary x-ray system. However, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (for training or testing), ground truth establishment, or expert qualifications necessary to answer the request.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, thereby permitting it to be marketed. It focuses on regulatory aspects like compliance with federal regulations, registration, labeling, and good manufacturing practices.
Therefore, I cannot provide the requested table or details about the study because the information is not present in the given text.
§ 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.