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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 K963363
Device Name HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
Applicant
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Applicant Contact ERIC VON STETTEN, PH.D.
Correspondent
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Correspondent Contact ERIC VON STETTEN, PH.D.
Regulation Number892.1170
Classification Product Code
KGI  
Date Received08/27/1996
Decision Date 11/22/1996
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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