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The device is indicated for use as a magnetic resonance diagnostic device software application for non-invasive assessment of liver health and the generation, display and review of magnetic resonance medical image data.

The device produces quantified metrics and composite images from magnetic resonance medical image data which, when interpreted by a trained healthcare professional, yield information on liver tissue characteristics that may assist in clinical decisions.

LiverMultiScan is a standalone, post processing software as a medical device (SaMD). It enables the generation, display and review of magnetic resonance (MR) medical image data for non-invasive assessment of liver health based on imaging acquired during a single patient visit.

LiverMultiScan quantifies liver tissue characteristics from appropriately acquired MR datasets. It produces three quantitative metrics: iron-corrected T1 (cT1): which reflects fibro-inflammatory disease activity of the liver parenchyma, proton density fat fraction (PDFF): a measure of liver fat content, and liver iron concentration (LIC). Each of these metrics is standardized to a single reference, ensuring that reference ranges and clinical thresholds can be applied consistently, regardless of the MRI scanner used to acquire the measurement. cT1, PDFF and LIC all have a valid and well-founded correlation with liver histology and are associated with pathological processes such as fibro-inflammation, steatosis, and iron overload, respectively.

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