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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 K163623
Device Name Quantra
Applicant
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact Neil Kelly
Correspondent
Hologic, Inc.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact Neil Kelly
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/22/2016
Decision Date 10/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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