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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 K071570
Device Name GE LUNAR BODY COMPOSITION SOFTWARE
Applicant
Ge Medical Systems Lunar
726 Heartland Trl.
Madison,  WI  53717
Applicant Contact JAMES P RASKOB
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/08/2007
Decision Date 06/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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