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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 K222968
Device Name Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Janine F Reyes
Canon Medical Systems USA, Inc.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Janine F Reyes
Regulation Number892.1000
Classification Product Code
Date Received09/27/2022
Decision Date 10/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls