Vantage Galan 3T, MRT-3020, 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 Galan 3t, Mrt-3020, V6.0.

Pre-market Notification Details

Device IDK192506
510k NumberK192506
Device Name:Vantage Galan 3T, MRT-3020, V6.0
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentJanine Reyes
Canon Medical Systems USA 2441 Michelle Drive Tustin,  CA  92780
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-12
Decision Date2020-03-02

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