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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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