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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 K202210
Device Name Vantage Orian 1.5T, MRT-1550, V6.0
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 Received08/06/2020
Decision Date 09/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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