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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 K060111
Device Name IVA (MXA II SOFTWARE OPTION)
Applicant
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Applicant Contact JEANETTE SCHIER-PUGSLEY
Correspondent
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact JEANETTE SCHIER-PUGSLEY
Regulation Number892.1170
Classification Product Code
KGI  
Date Received01/17/2006
Decision Date 04/24/2006
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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