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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 K173382
Device Name Vantage Galan 3T, V4.6
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 F. Reyes
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/30/2017
Decision Date 01/26/2018
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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