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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 K905691
Device Name QDR-1000 AND WITH X-RAY BONE DENSITOMETER
Applicant
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Applicant Contact VON STETTEN
Correspondent
Hologic, Inc.
590 Lincoln St.
Waltham,  MA  02154
Correspondent Contact VON STETTEN
Regulation Number892.1170
Classification Product Code
KGI  
Date Received12/19/1990
Decision Date 05/15/1991
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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