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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 K211633
Device Name Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
1385 Shimoshigami
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 Received05/27/2021
Decision Date 07/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No