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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 K122613
Device Name VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
Applicant
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780
Applicant Contact CHARLEMAGNE CHUA
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact CHARLEMAGNE CHUA
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/27/2012
Decision Date 12/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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