R 333.5603 Definitions.

Rule 603. (1) As used in this part the definitions in 21 C.F.R. 900.2, “Definitions” (2002), are adopted by reference with the exception of the definition of “mammography.” (2) As used in this part the following definitions apply: (a) “Interpreting physician” means a physician who interprets mammograms and who meets the requirements of R 333.5627 to R 333.5629. (b) "Mammography" means radiography of the breast for the purpose of enabling a physician to determine the presence, size, location, and extent of cancerous or potentially cancerous tissue in the breast. Mammography includes interventional mammography. (c) “Stereotactic breast biopsy” means the imaging of a breast performed in at least 2 planes to localize a target lesion during invasive interventions for biopsy procedures. (d) “Stereotactic breast biopsy physician” means a physician who conducts stereotactic breast biopsy.