R 333.5676 Equipment requirements.

Rule 676. (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) A machine that is used for stereotactic breast biopsy shall be 1 of the following: (a) A radiation machine that is specifically designed to perform stereotactic breast biopsy. (b) A mammography machine with a specially designed add-on device for breast biopsy. (c) A mammography machine that exclusively uses lateral arm devices if the needle can be seen in 2 ways in relation to the target lesion.