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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholanqiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan,Cine Imaging and Cardiac tagging.]
• Fluid Visualization .
• 2D / 3D Imaging ●
• MR Angiography / MR Vascular Imaging .
• . Blood Oxygenation Level Dependent (BOLD) imaging
• Perfusion / Diffusion Imaging .
• Proton Spectroscopy .

The EXCELART Vantage™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.

• New gantry design as Ultra-short bore. .
• . New patient couch design as wide couch top.
• It is possible to combine detachable couch top and gurney of exclusive use. .
• . The CPU of computer system was changed from RISC type to Xeon.
• . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
• . SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
• The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
• The gating waveform can be displayed by the side of the gantry. .

This document describes a 510(k) submission for the EXCELART Vantage™ XGV/AGV MRI system. The submission focuses on demonstrating substantial equivalence to a predicate device, the EXCELART™ with Pianissimo XG/AG SPIN Edition.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on comparing the safety and imaging performance parameters of the new device to its predicate. The acceptance criteria essentially align with maintaining or improving upon the predicate device's specifications, particularly within regulated safety limits.

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