(25 days)
The Konica Direct Digitizer Model 170 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.
Not Found
The provided text is a 510(k) substantial equivalence letter for a medical device called "Direct Digitizer REGIUS Model 150" and "Konica Direct Digitizer Model 170." It does not contain any information about acceptance criteria, device performance, a study conducted, sample sizes, ground truth establishment, or expert involvement.
The letter primarily focuses on the regulatory aspects of device approval, stating that the device is substantially equivalent to a legally marketed predicate device. It confirms that the device can be marketed subject to general controls and potential additional special controls.
Therefore, I cannot provide the requested information based on the input 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.