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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K142037
Device Name QUANTRA
Applicant
HOLOGIC, INC.
2585 AUGUSTINE DR
SANTA CLARA,  CA  95054
Applicant Contact CATHERINE WILLIAMS
Correspondent
HOLOGIC, INC.
2585 AUGUSTINE DR
SANTA CLARA,  CA  95054
Correspondent Contact CATHERINE WILLIAMS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/28/2014
Decision Date 10/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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