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U.S. Department of Health and Human Services

Radiation-Emitting Products

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What is the intent of the requirement that these paddles "meet the manufacturer's design and maintenance specifications"?

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Conventional paddles are designed to provide essentially flat compression across the breast to yield a uniform thickness of tissue for the mammographic study. However, some systems incorporate paddles designed to provide uniform compression pressure rather than thickness. Such systems must continue to operate consistent with their design over the life of the unit. This requirement simply states that the facility must maintain the system to the manufacturers' specifications.

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