Vantage Galan 3T, MRT-3020, V6.0 With AiCE Reconstruction Processing Unit For MR

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 With Aice Reconstruction Processing Unit For Mr.

Pre-market Notification Details

Device IDK192574
510k NumberK192574
Device Name:Vantage Galan 3T, MRT-3020, V6.0 With AiCE Reconstruction Processing Unit For MR
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentPaul Biggins
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 Received2019-09-19
Decision Date2020-03-09

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