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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.

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