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

by Canon Medical Systems Corporation 3 variants

510(k) K203323

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203323 Date4 Mar 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is a magnetic resonance imaging (MRI) system designed for high-field imaging. It integrates advanced reconstruction processing capabilities to enhance image quality and diagnostic accuracy. The system is part of Canon Medical Systems Corporation's portfolio of medical imaging solutions.

The device is supplied as a single-use system and requires proper storage in a controlled environment. It is not reusable and is intended for use in clinical settings under the supervision of trained personnel. The system is regulated under FDA 510(k) clearance, with a decision date of March 4, 2021, and is classified under product code LNH.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Vantage Galan 3T MRT-3020 MRI system used for?

    This MRI system is designed for high-field magnetic resonance imaging, providing advanced image quality and diagnostic accuracy for clinical use.

  • Is the Vantage Galan 3T MRT-3020 MRI system reusable?

    No, the system is supplied as a single-use device and is not intended for reuse.

  • What is the regulatory status of the Vantage Galan 3T MRT-3020 MRI system?

    The device is regulated under FDA 510(k) clearance, with a decision date of March 4, 2021.

  • How should the Vantage Galan 3T MRT-3020 MRI system be stored?

    The system requires proper storage in a controlled environment to maintain its performance and safety.