FDA 510(k) Application Details - K203106

Device Classification Name	More FDA Info for this Device
510(K) Number	K203106
Device Name	Nio Fusion 12MP (MDNC-12130)
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	10/15/2020
Decision Date	11/10/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review