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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 K120778
Device Name BRIVO MR355
Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO.2, YONG CHANG NORTH RD.
BEIJING ECON.&TECH.DEV.AREA
BEIJING,  CN 100176
Applicant Contact RUOQIAN LIU
Correspondent
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO.2, YONG CHANG NORTH RD.
BEIJING ECON.&TECH.DEV.AREA
BEIJING,  CN 100176
Correspondent Contact RUOQIAN LIU
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/14/2012
Decision Date 03/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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