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The MRI-Q System is intended to provide additional processing of images for the analysis of multi-slice gradient echo MRI data sets of cardiac tissue to quantify the signal decay rate (R2*) and time (T2*).

The MRI-Q System is a software device that provides quantitative analysis of magnetic resonance image signal decay parameters in cardiac tissue. The device contains an image viewer for importing DICOM images, browsing through datasets and performing quantitative region of interest analysis. The software device has capability to measure the signal decay rate (R2*) and time (T2*) in heart tissue.

Stand alone software package used to facilitate the import, visualization and analysis of multi-slice gradient echo MRI data sets encompassing cardiac tissue, to quantify the signal decay rate (R2*) and time (T2*).

This document is a 510(k) summary for the MRI-Q System, a software device for analyzing cardiac MRI data. It does not contain the specific details about acceptance criteria, study design, or performance metrics that would typically be found in a study report. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria based only on the provided text.

However, I can extract information related to the device description and intended use, which are foundational for any performance criteria:

Device Description and Intended Use:

• Function: Standalone software package used to facilitate the import, visualization, and analysis of multi-slice gradient echo MRI data sets encompassing cardiac tissue.
• Quantifies: Signal decay rate (R2*) and time (T2*).
• Operational Principle: Based on fitting signal decay curves to magnetic resonance image signal intensities acquired at different echo times on a voxel-by-voxel (3-D pixel) basis to determine R2* and T2*.
• Intended Use: To provide additional processing of images for the analysis of multi-slice gradient echo MRI data sets of cardiac tissue to quantify the signal decay rate (R2*) and time (T2*).
• Specific Capabilities: Image viewer for importing DICOM images, browsing datasets, and performing quantitative region of interest analysis.

To answer the specific questions about acceptance criteria and study details, more comprehensive information, typically found in a clinical study report or a more detailed section of the 510(k) submission, would be required. The provided text is a summary for regulatory approval, comparing the new device to existing predicate devices, rather than a detailed performance study report.

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