BRIVO MR355, OPTIMA MR360


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K103330
Device Name BRIVO MR355, OPTIMA MR360
Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
no.2, yong chang north rd.
beijing econ.&tech.dev.zone
beijing, 

CN

100176

Applicant Contact ruoqian liu
Correspondent
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
no.2, yong chang north rd.
beijing econ.&tech.dev.zone
beijing, 

CN

100176

Correspodent Contact ruoqian liu
Regulation Number 892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received 11/12/2010
Decision Date 02/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes

Recalls CDRH Recalls