FDA 510(k) Application Details - K113663

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K113663
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	UltraSonix Medical Corporation 130-4311 VIKING WAY RICHMOND, BRITISH COLUMBIA V6V 2K9 CA Other 510(k) Applications for this Company
Contact	CHAS YU Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2011
Decision Date	01/25/2012
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	Y
Expedited Review