FDA 510(k) Application Details - K151505

Device Classification Name	More FDA Info for this Device
510(K) Number	K151505
Device Name	Coronis Uniti
Applicant	Barco N.V. President Kennedypark 35 Kortrijk 8500 BE Other 510(k) Applications for this Company
Contact	Franky Dubois 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	06/04/2015
Decision Date	07/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review