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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 K230355
Device Name Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
Applicant
Canon Medical Systems Corporation
1385 Shimoshigami
Otawara-shi,  JP 324-8550
Applicant Contact Janine F Reyes
Correspondent
Canon Medical Systems USA, Inc.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Janine F Reyes
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/09/2023
Decision Date 08/30/2023
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
Recalls CDRH Recalls
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