SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K081110
Device Name SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
Applicant
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
7263 cronin circle
dublin, 
CA 
94568

Applicant Contact bob leiker
Correspondent
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
7263 cronin circle
dublin, 
CA 
94568

Correspodent Contact bob leiker
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 04/18/2008
Decision Date 05/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No