R 333.5703 Definitions.

Rule 703. (1) As used in this part the definitions in 21 C.F.R. 1020.33, “Computed tomography (CT) equipment” (June 10, 2005), are adopted by reference. Copies of these regulations are available for no cost from either of the following sources: (a) The website of the Michigan department of licensing and regulatory affairs, radiation safety section at http://www.michigan.gov/rss. (b) The website of the United States department of health & human services, U.S. food and drug administration at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm. (2) As used in this part the following definitions apply: (a) "Computed tomography (CT)" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data. Computed tomography includes the capability of producing axial tomograms. (b) "CT medical event" means an unintended event where a physician determines that actual damage has occurred to an organ or a physiological system of an individual due to or suspected to be due to exposure to diagnostic radiation from a CT scanner. (c) "CT scanner" means a CT machine capable of performing CT scans of the head, other body parts, or full body patient procedures including PET/CT and SPECT/CT scanner hybrids if used for CT only procedures. (d) "Medical physicist" means an individual trained in evaluating the performance of CT scanners, related equipment, and facility quality assurance programs and who meets the requirements in R 333.5707. (e) "Positron emission tomography (PET)" means an imaging technique that uses positron-emitting radionuclides to produce 3-dimensional images of functional processes in the body. (f) "Radiologic technologist" means an individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and who meets the requirements in R 333.5705. (g) "Single photon emission computed tomography (SPECT)" means an imaging technique that uses radionuclides to produce 3-dimentional images of functional processes in the body. (h) "Tomogram" means the depiction of the attenuation properties of a section through a body.