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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact RUOQIAN LIU
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/12/2010
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
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