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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 K193097
Device Name Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
otawara-shi,  JP 324-8550
Applicant Contact paul biggins
Correspondent
Canon Medical Systems USA
2441 Michelle Drive
tustin,  CA  92780
Correspondent Contact janine f. reyes
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/07/2019
Decision Date 07/14/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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