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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
Applicant
GE HEALTHCARE JAPAN CORPORATION
7-127, ASAHIGAOKA 4-CHROME
HINO-SHI, TOKYO,  JP 191-8503
Applicant Contact TORU SHIMIZU
Correspondent
GE HEALTHCARE JAPAN CORPORATION
7-127, ASAHIGAOKA 4-CHROME
HINO-SHI, TOKYO,  JP 191-8503
Correspondent Contact TORU SHIMIZU
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received11/12/2010
Decision Date 09/30/2011
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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