ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K111227
Device Name ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
ALOKA CO., LTD.
10 fairfield blvd.
wallingford, 
CT 
06492 -7502

Applicant Contact yukitoshi kiyomura
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 05/02/2011
Decision Date 05/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No