Trex' Full-Field Digital Mammography 510(k) Considered Withdrawn - FDA
This article was originally published in The Gray Sheet
Executive Summary
Trex Medical's pending 510(k) submission for its full-field digital mammography system is now considered "withdrawn" by FDA since the agency "was unable to determine substantial equivalence with analog, or 'film screen,' mammography" based on data submitted by the firm, Trex states in a Dec. 17 release.
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