FDA 510(k) Application Details - K143157

Device Classification Name	More FDA Info for this Device
510(K) Number	K143157
Device Name	Coronis Fusion 4MP LED
Applicant	BARCO NV 35 PRESIDENT KENNEDYPARK KORTRIJK BE Other 510(k) Applications for this Company
Contact	LIEVEN DE WANDEL 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	11/03/2014
Decision Date	11/12/2014
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