Vantage Elan 1.5T, MRT-2020, V6.0

System, Nuclear Magnetic Resonance Imaging

Canon Medical Systems Corporation

The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Vantage Elan 1.5t, Mrt-2020, V6.0.

Pre-market Notification Details

Device IDK210164
510k NumberK210164
Device Name:Vantage Elan 1.5T, MRT-2020, V6.0
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Canon Medical Systems Corporation 1385 Shimoshigami Otawara-shi,  JP 324-8550
ContactJanine F. Reyes
CorrespondentJanine F. Reyes
Canon Medical Systems USA, INC. 2441 Michelle Drive Tustin,  CA  92780
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-03-10

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