FDA 510(k) Application Details - K172574

Device Classification Name	More FDA Info for this Device
510(K) Number	K172574
Device Name	SyncVision System
Applicant	Volcano Corporation 3721 Valley Ctr. Dr. San Diego, CA 92130 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	08/28/2017
Decision Date	10/05/2017
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