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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 K140909
Device Name MCKESSON RADIOLOGY
Applicant
MCKESSON MEDICAL IMAGING COMPANY
5995 WINWARD PARKWAY
ALPHARETTA,  GA  30005
Applicant Contact PAUL SUMNER
Correspondent
MCKESSON MEDICAL IMAGING COMPANY
5995 WINWARD PARKWAY
ALPHARETTA,  GA  30005
Correspondent Contact PAUL SUMNER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/09/2014
Decision Date 07/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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