(30 days)
The Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing. The REGIUS MODEL 370 is NOT intended for use with digital mammography system.
The Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing.
I am sorry, but the provided document does not contain information about acceptance criteria and a study that proves the device meets those criteria. The document is a 510(k) clearance letter for the Direct Digitizer REGIUS Model 370, which confirms its substantial equivalence to legally marketed predicate devices and outlines its intended use. It does not include details on specific performance acceptance criteria, study methodologies, or results.
§ 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.