A Guide for the submission of initial reports on computed tomography x-ray systems
U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, Office of Radiological Products, X-Ray Products Branch, 1985 - Medical - 17 pages
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DEFINITIONS til PART 100 IDENTIFICATION
11 other sections not shown
allowable line-voltage regulation beam beam-limiting device calibration centimeters Common Aspects Report computed tomography conditions of operation Conditions Please note critical parameters CT conditions data for worst describe any critical deviation statements provided diagnostic source assembly dose dosimeter(s drawing or picture exceed the limits factors and supply highest kW information as outlined INITIAL REPORTS instrument is commercially LEAKAGE RADIATION limits given line conditions e.g. manufacturer and model maximum allowable line-voltage maximum deviation statements maximum-rated peak tube measurement instrument model number Modulation transfer function multiple tomogram system nominal tomographic section note and describe outlined in Attachment parameters and worst peak tube potential phantom photons preindicated value Provide information reference plane Requirement The manufacturer results must include scanning mechanism standard deviation supply line conditions system or test technique factors test method tomographic plane tomographic section thickness tube housing assemblies unique visual indication x-ray control x-ray system x-ray transmission data x-ray tube