E-CUBE 9


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K111864
Device Name E-CUBE 9
Applicant
ALPINION MEDICAL SYSTEMS CO., LTD
suite 226, 10604
ne 38th place
kirkland, 
WA 
98033

Applicant Contact yuchi chu
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 06/30/2011
Decision Date 07/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No