Vantage Galan 3T, MRT-3020, V8.0 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, V8.0 With Aice Reconstruction Processing Unit For Mr.

Pre-market Notification Details

Device IDK222387
510k NumberK222387
Device Name:Vantage Galan 3T, MRT-3020, V8.0 With AiCE Reconstruction Processing Unit For MR
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-08
Decision Date2022-08-31

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