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U.S. Department of Health and Human Services

Radiation-Emitting Products

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What testing do the various FFDM manufacturers require for a new unit mammography equipment evaluation (MEE)?

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A table summarizing FFDM manufacturer’s testing requirements for new unit mammography equipment evaluations is available on the following webpage:

http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114138.htm

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