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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 K162183
Device Name Vantage Galan 3T, MRT-3020, V4.0
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
1385 SHIMOISHIGAMI
Otawara-shi,  JP 324-8550
Applicant Contact PAUL BIGGINS
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DRIVE
TUSTIN,  CA  92780
Correspondent Contact Janine Faith Reyes
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/04/2016
Decision Date 11/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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