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

510(k) K230355

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK230355	Date30 Aug 2023Cleared	StatusActive

2 recalls · 2 ongoing · FDA

- Ongoing Z-1017-2026 FDA Class II initiated 19 Dec 2025
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 via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
- Ongoing Z-2041-2024 FDA Class II initiated 10 May 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, followed by melting of the cable, ignition, smoke, and fire.

1 jurisdiction

United States — FDA 510(k) Active

510(k)