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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 K103385
Device Name SECURVIEW DX DIAGNOSTIC WORKSTATION
Applicant
HOLOGIC, INC.
36 APPLE RIDGE ROAD
DANBURY,  CT  06810
Applicant Contact GAIL YAEKER-DAUNIS
Correspondent
HOLOGIC, INC.
36 APPLE RIDGE ROAD
DANBURY,  CT  06810
Correspondent Contact GAIL YAEKER-DAUNIS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/18/2010
Decision Date 02/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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