Section 325.5637. X-ray equipment; requirements.

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(1) The mammographic x-ray equipment shall be maintained in compliance with the applicable regulations in 21 C.F.R. 1020.30, “Diagnostic x-ray systems and their major components” (2007), and 21 C.F.R. 1020.31, “Radiographic equipment” (2005).

(2) The mammography machine, x-ray film, intensifying screens, film processing solutions, film illumination, and film masking devices shall meet the requirements of 21 C.F.R. 900.12 (b), “Equipment” (2000).

History: 1993 AACS; 2013 AACS.

                    
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