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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 K102489
Device Name VANTAGE TITAN 3T
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2241 MICHELLE DR
TUSTIN,  CA  92780
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
2241 MICHELLE DR
TUSTIN,  CA  92780
Correspondent Contact PAUL BIGGINS
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received08/31/2010
Decision Date 08/02/2011
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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