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FDA Panel To Consider If Digital Mammography Is Ready For 510(k)

This article was originally published in The Gray Sheet

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Executive Summary

FDA's Radiological Devices Panel will consider reclassifying full-field digital mammography systems as Class II rather than Class III devices nearly a decade after imaging manufacturers first pushed for the classification, which would require a lower threshold of data in premarket submissions
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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