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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
Model MDNG-6121
Device Name NIO 5MP
Original Applicant
BARCO NV
35 president kennedypark
kortrijk,  BE 8500
Original Contact lieven de wandel
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/18/2012
Decision Date 07/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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