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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
Recalls CDRH Recalls
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