ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K112339
Device Name ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
SAMSUNG MEDISON CO., LTD
1003 daechi-dong,
gangnam-gu
seoul, 

KR

135-280

Applicant Contact kyeong-mi park
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 08/15/2011
Decision Date 08/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No