Radiation-Emitting Products

Can a facility use printers and monitors that were not specifically approved as part of its FFDM unit?

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FDA recommends that only printers and monitors specifically approved or cleared for FFDM use by FDA’s Office of Device Evaluation be used. However, a facility may use other printers and monitors. Facilities need to ensure that all printers and monitors used by the facility with its FFDM unit comply with a quality assurance program that is substantially the same as that recommended by the FFDM manufacturer and pass the facility’s accreditation body’s phantom and clinical image review process. At the current time, no accreditation body reviews soft copy images so we recommend that the soft copy images be of such quality that if they were submitted they would pass the facility’s accreditation body’s phantom and clinical image review process.

Note: Each softcopy and hardcopy mammographic image used for final interpretation must indicate identifying information (view and laterality, technologist identification, patient name, etc.) (21 CFR 900.12(c)(5)).

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Page Last Updated: 06/26/2014
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