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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 K110494
Device Name SYNGO MBF
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60192
Applicant Contact ELAINE CHANG
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60192
Correspondent Contact ELAINE CHANG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/22/2011
Decision Date 04/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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