Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

The Vantage Fortian/Orian 1.5T is a 1.5 Tesla magnetic resonance imaging (MRI) system that produces cross-sectional images of anatomic structures of the head or body using nuclear magnetic resonance properties of protons. It can generate transaxial, coronal, sagittal, and oblique images and is capable of non-contrast enhanced imaging such as MRA, with potential use of contrast agents depending on clinical need.

This V10.0 device adds four software enhancements to the V9.0 predicate: 4D Flow (blood flow visualization with quantitative analysis), Zoom DWI (diffusion imaging with reduced FOV and artifact suppression), PIQE extension (deep learning-based image reconstruction extended to additional anatomies and weightings), and minor system software updates. A new optional Breast SPEEDER pad kit accessory was added. Safety parameters, static field strength (1.5T), SAR limits, and imaging performance remain unchanged from the predicate.

Testing followed IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-33:2010, IEC 62304:2006, IEC 62366-1:2020, ISO 10993-1:2018, and NEMA MS standards (MS 1-5). Risk management and verification/validation testing were conducted per established medical device development standards and consensus guidance.

The device maintains identical static field strength, operational modes, SAR limits, dB/dt limits, and emergency shutdown mechanisms as the V9.0 predicate. Software additions (4D Flow, Zoom DWI, PIQE extension) are post-processing enhancements to existing imaging capabilities with no changes to indications for use or intended use. PIQE extension was validated using the same performance testing methodology applied in a reference 3T submission (K243335), with clinical image review demonstrating maintained or improved image quality metrics across additional anatomies. The Breast SPEEDER pad kit is a passive accessory with no functional impact on device safety or performance.