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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K261469
Device Name Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).
Applicant
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Eric Caus
Correspondent
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Eric Caus
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received05/04/2026
Decision Date 09/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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