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The R2-MRI Analysis System is an accessory diagnostic device to International for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.

Software tool used as an accessory to an MR scanning machine, to facilitate the import and visualization of data sets encompassing the multi-slice, spin-echo MRI independent of the MRI equipment vendor, to provide objective and reproducible determination of liver parameters to support clinicians in the assessment of liver iron status.

The provided document, a 510(k) summary for the R2-MRI Analysis System, describes the device and its intended use but does not contain specific details about acceptance criteria, a study proving device performance against those criteria, or information on training/test sets as requested.

The 510(k) focuses on demonstrating substantial equivalence to predicate devices. It lists the R2-MRI Analysis System's intended use as: "For the analysis of multi-slice, spin-echo MRI data sets of the liver for the measurement of liver R2 and liver iron concentration." and "Supporting clinical diagnoses about the status of liver iron concentration."

Without a performance study or acceptance criteria outlined in this document, the requested information cannot be directly extracted. The document primarily establishes regulatory classification and comparison to existing devices.

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