FDA 510(k) Application Details - K093462

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K093462
Device Name	Transducer, Ultrasonic, Diagnostic
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	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2009
Decision Date	11/20/2009
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