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FDA 510(k)

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

K-Number: K243335 · 2025-01-07

ApplicantCanon Medical Systems Corporation
Decision Date2025-01-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2025-01-07 under approval number K243335. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR?

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a medical device that received FDA 510(k) clearance on 2025-01-07. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K243335.

When was Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR approved by the FDA?

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR received FDA 510(k) clearance on 2025-01-07, under approval number K243335.

What company makes Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR?

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR?

The FDA product code for Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is LNH.

Related Clinical Trials

NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED

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K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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