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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 K802180
Device Name WISCONSIN DUAL-PHOTON BONE ANALYZER
Applicant
Lunar Radiation Corp.
WI 
Correspondent
Lunar Radiation Corp.
WI 
Regulation Number892.1170
Classification Product Code
KGI  
Date Received09/09/1980
Decision Date 12/31/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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