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

The Vantage Galan 3T is a 3 Tesla magnetic resonance imaging (MRI) system that produces cross-sectional images of the head and body to display anatomical structures. It can perform diagnostic imaging using various NMR properties (proton density, T1, T2, flow dynamics, chemical shift) and supports non-contrast enhanced imaging such as MRA, with optional contrast agents for diagnosis.

The subject device adds a Standard Gradient (STD) system compatible with V10.0 hardware and software updates, using the same gradient amplifier as the reference device. The Precise IQ Engine (PIQE) deep learning technique was extended from the predicate to additional scan families, weightings, and anatomical regions (Body, Breast, Cardiac, MSK, Neuro) to generate higher in-plane matrix images while mitigating ringing artifacts. Minor system software updates were also made.

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-33:2010, IEC 62304:2006, ISO 10993-1:2018, NEMA MS 1–5, ANSI AAMI ES60601-1:2005, IEC 60825-1:2014, IEC 62366-1:2020, and IEC 60601-1-6:2010.

The subject device is substantially equivalent because it maintains the same 3T static field strength, operational modes, safety parameters (SAR, dB/dt limits), and indications for use as the predicate K241496. The Standard Gradient system uses identical hardware to the reference device, and PIQE was extended to new anatomies using the same established bench testing methodology and clinical review protocol with 14 board-certified radiologists across multiple sites. All imaging performance parameters remain unchanged, and risk management and design controls were applied consistently with predicate standards.