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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 K941127
Device Name QCT-BONE MINERAL ANALYSIS SOFTWARE
Applicant
Image Analysis, Inc.
104 Public Sq.
Columbia,  KY  42728
Applicant Contact BEN ARNOLD, PH.D
Correspondent
Image Analysis, Inc.
104 Public Sq.
Columbia,  KY  42728
Correspondent Contact BEN ARNOLD, PH.D
Regulation Number892.1170
Classification Product Code
KGI  
Date Received03/09/1994
Decision Date 05/11/1995
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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