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

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This document is a 510(k) clearance letter from the FDA for a medical device called "Combi Elevator-2 & Combi Elevator-2 Microtom." It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses solely on the regulatory approval and indications for use. Therefore, I cannot provide the requested information based on the provided text.

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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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