Radiation-Emitting Products

Mammography (Definition)

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900.2(aa) Mammography means radiography of the breast, but, for the purposes of this part, does not include: (1) Radiography of the breast performed during invasive interventions for localization or biopsy procedures; or (2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA’s investigational device exemption regulations in part 812 of this chapter.

Page Last Updated: 07/25/2014
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