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U.S. Department of Health and Human Services

Radiation-Emitting Products

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In 21 CFR 900.12(b)(6)(i) what does the phrase "available for use by the operator" mean?

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X-ray systems used for noninterventional problem-solving mammography are required to have the capability for magnification "available for use by the operator." This means that any necessary magnification devices or attachments must be present so that the operator can perform magnification procedures. The decision on whether to use magnification still rests with the facility.

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