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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 K983262
Device Name FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
Applicant
Lunar Corp.
313 W. Beltline Hwy.
Madison,  WI  53713
Applicant Contact KENNETH D BUROKER
Correspondent
Lunar Corp.
313 W. Beltline Hwy.
Madison,  WI  53713
Correspondent Contact KENNETH D BUROKER
Regulation Number892.1170
Classification Product Code
KGI  
Date Received09/17/1998
Decision Date 11/18/1998
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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