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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K072258
Device Name BI-RADS COMPANION
Applicant
Almen Laboratories, Inc.
6319 Massachusetts Ave.
Bethesda,  MD  20816 -1139
Applicant Contact ROGER H SCHNEIDER
Correspondent
Almen Laboratories, Inc.
6319 Massachusetts Ave.
Bethesda,  MD  20816 -1139
Correspondent Contact ROGER H SCHNEIDER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/14/2007
Decision Date 05/16/2008
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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