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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
Applicant
Ge Medical Systems Lunar
3030 Ohmeda Dr.
Madison,  WI  53718
Applicant Contact TRISHIA DWYER
Correspondent
Ge Medical Systems Lunar
3030 Ohmeda Dr.
Madison,  WI  53718
Correspondent Contact TRISHIA DWYER
Regulation Number892.1170
Classification Product Code
KGI  
Date Received11/07/2011
Decision Date 04/27/2012
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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