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 designed to produce cross-sectional images of the head and body for diagnostic purposes. It can acquire transaxial, coronal, sagittal, and oblique images and supports non-contrast enhanced imaging such as MRA (magnetic resonance angiography).

The subject device adds new model numbers with a modified ASGC (asymmetric shimming gradient coil) and expands the software upgrade package (V10.0) to support both conventional Vantage Orian systems and systems with the modified ASGC. Safety parameters, static field strength (1.5T), operational modes, maximum SAR (4W/kg), and emergency shutdown mechanisms remain identical to the predicate device.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 62366-1, ISO 10993-1, NEMA MS 1-5, and ANSI AAMI ES 60601-1. Risk analysis and verification/validation testing through bench testing were conducted; no image quality testing was performed.

The modifications do not change the device's indications for use or intended purpose. The subject device uses the same technologies, materials, and software as the predicate (K250901) and maintains identical safety parameters, imaging performance, and emergency shutdown capabilities. Risk management activities demonstrate that system requirements are met equivalently to the predicate.