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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 K183657
Device Name Vantage Galan 3T, MRT-3020/A9, V5.0
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems USA, Inc.
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact Janine F. Reyes
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/27/2018
Decision Date 03/15/2019
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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