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To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.

CS2000 & CS2000 Tomo (Radiographic table with integrated X-ray tube stand and tomograph

The provided document is a 510(k) premarket notification letter from the FDA for a radiographic table with an integrated X-ray tube stand and tomograph (CS2000 & CS2000 Tomo). This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed results as you've outlined.

Therefore, I cannot extract the requested information (1-9) from this document. The letter primarily confirms that the device is substantially equivalent for its stated indications for use: "To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician."

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