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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 K233693
Device Name Nio Color 8MP (MDNC-8132)
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Julie Vandecandelaere
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Julie Vandecandelaere
Regulation Number892.2050
Classification Product Code
Date Received11/17/2023
Decision Date 12/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No