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FDA 510(k)

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

K-Number: K203323 · 2021-03-04

ApplicantCanon Medical Systems Corporation
Decision Date2021-03-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2021-03-04 under approval number K203323. 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, V6.0 with AiCE Reconstruction Processing Unit for MR?

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is a medical device that received FDA 510(k) clearance on 2021-03-04. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K203323.

When was Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR approved by the FDA?

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR received FDA 510(k) clearance on 2021-03-04, under approval number K203323.

What company makes Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR?

Vantage Galan 3T, MRT-3020, V6.0 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, V6.0 with AiCE Reconstruction Processing Unit for MR?

The FDA product code for Vantage Galan 3T, MRT-3020, V6.0 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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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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