FDA 510(k) Application Details - K132558

Device Classification Name	More FDA Info for this Device
510(K) Number	K132558
Device Name	SYNC-RX SYSTEM
Applicant	VOLCANO CORPORATION 1 FORTUNE DRIVE BILLERICA, MA 01821 US Other 510(k) Applications for this Company
Contact	ELAINE ALAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2013
Decision Date	12/12/2013
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