Retrospective review of the performance standard for diagnostic x-ray systems and other major components (21 CFR 1020.30-32)
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PRIORITIES AND RESOURCE NEEDS
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Additional Resources Necessary aluminum equivalence amended assembler Benefits Overview C-arm CDRH Center certified components certified systems clip-on cassette holders coefficient of variation collimation compliance tests computed tomography Costs and Benefits Diagnostic X-Ray Equipment diagnostic x-ray systems dose reduction entrance exposure rate Equipment Performance Standard estimates Federal Register notice field limitation film fluoroscopic image intensifier image receptor imaging performance impact light localizer limitation and alignment linearity major components manufacturers NCRP noncompliance November 16 operation patient PBL requirement PBL systems percent primary protective barrier Problems and Disadvantages programs public health Purpose X-ray R/min radiation control radiation exposure radiation safety radiographic Rationale regulations regulatory Regulatory Flexibility Act reproducibility requirement response result retrospective review significant specific spot-film devices Standard for Diagnostic stepless adjustment technique factor accuracy uncertified variance x-ray beam X-Ray Equipment Performance x-ray field XSRG believes XSRG recommends