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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 K121788
Device Name NIO 5MP
Applicant
BARCO NV
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE 8500
Applicant Contact LIEVEN DE WANDEL
Correspondent
BARCO NV
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE 8500
Correspondent Contact LIEVEN DE WANDEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/18/2012
Decision Date 07/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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