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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 K262412
Device Name Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)
Applicant
Barco NV
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Lieven De Wandel
Correspondent
Barco NV
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Lieven De Wandel
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/15/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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