Radiation-Emitting Products

A facility performs non-mammographic breast imaging studies on the same day as the mammographic examination.

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Must the facility provide the patient a separate mammography lay summary, or can the facility provide a combined lay summary that represents the overall results and recommendations for all the breast imaging studies performed that day?

The facility has the option of providing either a separate mammography lay summary or a combined lay summary. FDA recommends that, where feasible, the facility provide a combined lay summary, so as to give the patient the most complete and useful information.

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Page Last Updated: 06/11/2014
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