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53 FR 1567, Jan. 20, 1988, unless otherwise noted.
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Subscribe to: 21 CFR 892.1200
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Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(b) Classification. Class II.