(193 days)
The Konica Direct Digitizer (Computed Radiography Device) Model DD-341/Regius 150 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.
Konica Direct Digitizer, Model DD-341/Regius 150 is a Computed Radiography Device.
This document is a 510(k) clearance letter for the Konica Direct Digitizer, Model DD-341/Regius 150. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter acknowledges the company's intent to market the device and states that the FDA has determined it is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies from the provided 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.