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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 K172878
Device Name Vantage Titan 3T, MRT-3010/A7, M-Power GX
Applicant
Toshiba Medical Systems Corporation, Japan
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact Paul Biggins
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/21/2017
Decision Date 11/17/2017
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
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