Document Detail

Electronic products; performance standard for diagnostic x-ray systems and their major components. Final rule.
MedLine Citation:
PMID:  15948306     Owner:  HSR     Status:  MEDLINE    
The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  70     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2005 Jun 
Date Detail:
Created Date:  2005-06-10     Completed Date:  2005-06-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  33997-4042     Citation Subset:  T    
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MeSH Terms
Costs and Cost Analysis
Diagnostic Equipment / standards
Electronics, Medical / legislation & jurisprudence,  standards*
Equipment Safety / standards*
Fluoroscopy / instrumentation,  standards*
International System of Units
Neoplasms / etiology,  mortality
Radiation Dosage*
Radiation Effects
Radiation, Ionizing
Radiography / instrumentation,  standards*
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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