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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 K133663
Device Name NIO COLOR 2MP
Applicant
Barco N.V.
35 President Kennedypark
Kortrijk,  BE
Correspondent
Barco N.V.
35 President Kennedypark
Kortrijk,  BE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/29/2013
Decision Date 03/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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