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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 K113286
Device Name ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
Original Applicant
GE MEDICAL SYSTEMS LUNAR
3030 ohmeda dr
madison,  WI  53718
Original Contact trishia dwyer
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/09/2011
Decision Date 04/27/2012
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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