FDA 510(k) Application Details - K191845

Device Classification Name	More FDA Info for this Device
510(K) Number	K191845
Device Name	Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
Applicant	Barco NV President Kennedypark 35 Kortrijk 8500 BE Other 510(k) Applications for this Company
Contact	Julie Vandecandelaere Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2019
Decision Date	09/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review