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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K170476
Device Name Nio Color 5.8MP (MDNC-6121)
Applicant
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Helena Soenen
Correspondent
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Helena Soenen
Regulation Number892.2050
Classification Product Code
PGY  
Date Received02/16/2017
Decision Date 03/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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