21 C.F.R. § 892.1740 Tomographic x-ray system.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1740 Tomographic x-ray system.