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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 K103327
Device Name DISCOVERY MR750W 3.0T
Original Applicant
GE HEALTHCARE JAPAN CORPORATION
7-127, asahigaoka 4-chrome
hino-shi, tokyo,  JA 191-8503
Original Contact toru shimizu
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received11/15/2010
Decision Date 09/30/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
Recalls CDRH Recalls
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