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53 FR 1567, Jan. 20, 1988, unless otherwise noted.
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Subscribe to: 21 CFR 892.1750
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Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(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.