Mich. Admin. Code R. 333.5676

Current through Vol. 24-24, January 15, 2025

Section 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.

Mich. Admin. Code R. 333.5676

2016 MR 10, Eff. 5/25/2016