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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 K203106
Device Name Nio Fusion 12MP (MDNC-12130)
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 Received10/15/2020
Decision Date 11/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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