(251 days)
To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.
Not Found
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.
§ 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.