R 333.5637 X-ray equipment; requirements.

Rule 637. (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).