SONIX MDP ULTRASOUND SCANNER


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K080935
Device Name SONIX MDP ULTRASOUND SCANNER
Applicant
UltraSonix Medical Corporation
130-4311 viking way
richmond, british columbia, 

CA

v6v 2k9

Applicant Contact alan remfry
Correspondent
UltraSonix Medical Corporation
130-4311 viking way
richmond, british columbia, 

CA

v6v 2k9

Correspodent Contact alan remfry
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 04/02/2008
Decision Date 08/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No