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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 K230520
Device Name Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
Applicant
Barco NV
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Julie Vandecandelaere
Correspondent
Barco NV
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Julie Vandecandelaere
Regulation Number892.2050
Classification Product Code
PGY  
Date Received02/27/2023
Decision Date 03/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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