THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K103722
Device Name THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
MEDISON CO., LTD.
1003 daechi-dong
gangnam-gu
seoul, 

KR

135-280

Applicant Contact park kyeong-mi
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received 12/21/2010
Decision Date 01/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No