Revision History


Because computed radiography (CR) is a form of FFDM and the image quality, QC and personnel requirements are different from screen-film, facilities using both screen-film and CR with the same mammography unit must accredit as 2 separate units. Although computed radiography (CR) and full-field digital mammography (FFDM) systems have significant physical differences, FDA treats them the same from an MQSA regulatory standpoint. CR systems are considered part of the FFDM mammographic modality. This means that facilities wishing to use a CR system must meet all applicable MQSA requirements, including those specific to FFDM units. For example, all personnel using a CR system must have completed at least 8 hours of training specific to digital mammography prior to using the new CR system on patients. However, because CR systems are part of the FFDM mammographic modality, personnel who have already obtained 8 hours of training in FFDM do not have to obtain another 8 hours in CR prior to use on patients.



Revision History for this Article

Date

Section

Description of Revision(s)

12-12-19

All

Article created; FAQs incorporated; No criteria changes



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