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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 K142850
Device Name McKesson Radiology Mammography Plus
Applicant
MCKESSON MEDICAL IMAGING COMPANY
130-10711 CAMBIE ROAD
RICHMOND, B.C.,  CA V6X 3G5
Applicant Contact GILBERT WONG
Correspondent
MCKESSON TECHNOLOGIES INC.
5995 WINDWARD PARKWAY
ALPHARETTA,  GA  30005
Correspondent Contact PAUL SUMNER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/30/2014
Decision Date 01/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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