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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, -The whole body (including reast). [Application terms include MR Fluoroscopy, MR Irography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
• Fluid Visualization -
• 2D/3D Imaging -
• MR Angiography/MR Vascular Imaging -

This submission consists of three upgrades to the MRT-150/H1 and MRT-150/F1 (VISART™) system. The first upgrades the software from V3.1 (which was the software cleared with the VISART™ in K961092) to V3.5. The second is the introduction of the VISART™/Hyper system, which increases the gradient field strength over that of the standard VISART™ with V3.5 software. The third is the introduction of optional phased array coils.

The provided text describes a 510(k) summary for a Magnetic Resonance Device (MRT-150/H1, MRT-150/F1, MRT-150/H2, MRT-150/F2, marketed as VISART and VISART/Hyper). It introduces upgrades to the software (from V3.1 to V3.5) and hardware (VISART/Hyper system with increased gradient field strength and optional phased array coils).

Here's an analysis based on the information provided, specifically addressing the questions you've posed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes safety and imaging performance parameters for the device. While explicit "acceptance criteria" for a study aren't clearly defined as pass/fail thresholds in the typical sense for a clinical study, the specifications listed for the upgraded devices represent the targeted performance that was demonstrated to be met.

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