SONIXGPS NEEDLE SENSOR


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K111818
Device Name SONIXGPS NEEDLE SENSOR
Applicant
UltraSonix Medical Corporation
130-4311 viking way
richmond, british columbia, 

CA

v6v 2k9

Applicant Contact chas yu
Regulation Number 892.1560
Classification Product Code
IYO  
Date Received 06/28/2011
Decision Date 06/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No