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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name densitometer, bone
510(k) Number K113356
Model QDR
Device Name HOLOGIC VISCERAL FAT SOFTWARE
Original Applicant
HOLOGIC, INC.
35 crosby dr.
bedford,  MA  01730
Original Contact eileen m boyle
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/14/2011
Decision Date 03/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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