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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 K120638
Model MRT-1504/U4
Device Name VANTAGE TITAN
Original Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle dr
tustin,  CA  92780
Original Contact paul biggins
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/01/2012
Decision Date 06/01/2012
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 No
Recalls CDRH Recalls
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