21 C.F.R. § 892.1750 Computed tomography x-ray system.
Title 21 - Food and Drugs
(a) Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. 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
§ 892.1750 Computed tomography x-ray system.