Beware of digital unit/PACS compatibility problems
Mammography Regulation and Reimbursement Report, September 1, 2008
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The FDA notified facilities with digital mammography units about technical compatibility problems whereby PACS might obscure critical information on mammography images.
The July 29 advisory states:
FDA has learned that when images from some FFDM units are displayed on some third-party PACS, the image identification information may obscure breast tissue on hard-copy images in violation of regulation 21 CFR 900.12(c)(5), or the view and laterality may not always appear near the axillary portion of the breast in either the soft- or hard-copy images as required by regulation 21 CFR 900.12(c)(5)(iii).
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