# K230355: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Aug 30, 2023 after 202 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K002531 (2000). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222387: Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR, Canon Medical Systems Corporation (2022) Summary page 5.

## Most influential descendants
- K241496: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (2024), 1 descendant of its own
- K243335: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (2025), 0 descendants of its own

## Recalls of this device
- Dec 19, 2025 · Class II · Z-1017-2026: There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape v
- May 10, 2024 · Class II · Z-2041-2024: The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followe

## Indications for use
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are: •Proton density (PD) (also called hydrogen density) •Spin-lattice relaxation time (T1) •Spin-spin relaxation time (T2) •Flow dynamics •Chemical Shift Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Source page: https://510kreport.com/device/K230355
Methodology: https://510kreport.com/methodology