FDA 510(k) Application Details - K172455

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K172455
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Courtney Moore Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2017
Decision Date	10/25/2017
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