Radiation-Emitting Products

We do not have a QC manual for our printers or monitors. What QC testing should we perform on our printers and monitors?

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Under 21 CFR 900.12(e)(6), facilities using a mammographic modality other than screen-film must follow a quality control program that is “substantially the same as the quality assurance program recommended by the image receptor manufacturer.” While all FFDM manufacturers have QC manuals, in some cases, the QC manual instructs the facility to test monitors and printers according to the component’s QC manual. In these cases, it is the responsibility of each facility to ensure that it obtains and follows the component’s QC manual for its monitors and printers.

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Page Last Updated: 08/11/2014
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