(204 days)
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."
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.