(267 days)
This Device is a digital X-Ray system intended for use in the field of diagnostic X-Ray. The resident physician would use this device just as if it were a film-based system.
This device is called Instant-X and is available as Model 1713 and Model 128. This Device is a digital X-Ray system.
This document describes the FDA's decision on the 510(k) premarket notification for the Instant-X Models 1713 & 128, a stationary x-ray system. It confirms that the device is substantially equivalent to legally marketed predicate devices.
Unfortunately, the provided text does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria. The document is primarily an FDA clearance letter and an "Indications for Use" statement.
Therefore, I cannot extract the information required for the table and points 1-9. The document only confirms the device's classification and its intended use as a digital X-Ray system for diagnostic X-Ray, to be used by a resident physician similar to a film-based system.
§ 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.