Brevera Biopsy System With Corlumina Imaging Technology

Instrument, Biopsy

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Brevera Biopsy System With Corlumina Imaging Technology.

Pre-market Notification Details

Device IDK163052
510k NumberK163052
Device Name:Brevera Biopsy System With Corlumina Imaging Technology
ClassificationInstrument, Biopsy
Applicant HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
ContactSarah Fairfield
CorrespondentSarah Fairfield
HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough,  MA  01752
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-01
Decision Date2017-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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15420045507838 K163052 000
15420045507852 K163052 000
35420045507801 K163052 000
35420045507832 K163052 000
15420045515161 K163052 000

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