(73 days)
The Direct Digital Radiography CCD Imaging Sensor, NAOMI provides digital image capture for conventional film / screen radiographic examinations. The device is intended to replace radiographic film / screen systems in all general-purpose diagnostic procedures. "The device must not be used for primary diagnosis in mammography."
Direct Digital Radiography CCD Imaging Sensor NAOMI
I am sorry but this document is a 510(k) substantial equivalence letter from the FDA. It does not contain information on the acceptance criteria, study details, or performance of the device. It primarily discusses the regulatory classification of the "Direct Digital Radiography CCD Imaging Sensor NAOMI" and its substantial equivalence to previously marketed devices. Therefore, I cannot provide the requested information based on this document.
§ 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.