CONTRAST ENHANCED DIGITAL MAMMOGRAPHY

Full Field Digital, System, X-ray, Mammographic

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Contrast Enhanced Digital Mammography.

Pre-market Notification Details

Device IDK123873
510k NumberK123873
Device Name:CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
ClassificationFull Field Digital, System, X-ray, Mammographic
Applicant HOLOGIC, INC. 35 CROSBY DR. Bedford,  MA  01730
ContactDeborah Thomas
CorrespondentDeborah Thomas
HOLOGIC, INC. 35 CROSBY DR. Bedford,  MA  01730
Product CodeMUE  
CFR Regulation Number892.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-17
Decision Date2013-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045512016 K123873 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.