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LiverSmart is indicated to: For Liver Iron Concentration 1. measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; 2. monitor liver iron burden in transfusion dependents and patients with sickle cell disease receiving blood transfusions: 3. aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. For Liver Fat Assessment 1. assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease. When interpreted by a trained physician, the results can be used to: 2. monitor liver fat content in patients undergoing weight loss management; 3. aid in the assessment and screening of living donors for liver transplant.

LiverSmart is software that utilizes two existing FDA cleared devices, HepaFat-AI (K201039) and FerriSmart (K182218) and combines their respective results into a singular consolidated multiparametric 'LiverSmart' report. LiverSmart automatically sorts and sends magnetic resonance imaging (MRI) datasets to each of the existing HepaFat-AI and FerriSmart devices and then receives results from those devices to generate a summary report which combines the HepaFat-AI results (an estimate of the patient's volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), steatosis grade), and the FerriSmat result (an estimate of the patient's liver iron concentration (LIC)). To conduct analysis, the user simply uploads a single zipped folder containing HepaFat-AI and FerriSmart DICOM images, acquired in accordance with their respective acquisition protocols, to the LiverSmart software. No user input is required for the analysis thereby minimising the impact of human error. The LiverSmart software requires image input data that has been acquired in accordance with the existing and now well established HepaFat-AI (K201039) and FerriSmart (K182218) imaging protocols. LiverSmart has two new components that are in addition to the existing components of HepaFat-AI and FerriSmart, namely a: - (i) Data Preparation Module; and - (ii) Report Generation Module The rest of the components for LiverSmart are the existing components of the FDA cleared HepaFat-AI and FerriSmart devices, as follows: For HepaFat-AI: - (i) Magnetic Resonance Imaging Protocol - (ii) HepaFat-AI Analysis Software - (iii) Volumetric Liver Fat Fraction Measurement - (iv) Proton Density Fat Fraction Measurement - (v) Steatosis Grade Measurement For FerriSmart: - (i) Magnetic Resonance Imaging Protocol - (ii) FerriSmart Analysis Software - (iii) Liver Iron Concentration Measurement The above HepaFat-AI and FerriSmart components are the same as previously provided to the FDA as the time HepaFat-AI and FerriSmart regulatory clearances were sought (and subsequently obtained).

FerriSmart is indicated to: · measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; · monitor liver iron burden in transfusion dependent thalassemia patients with sickle cell disease receiving blood transfusions: • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.

FerriSmart is a stand-alone software application that automatically analyses multi-slice, spin-echo MRI data sets encompassing the abdomen to determine the signal decay rate (R>) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo. The software application is a measuring medical device intended to be hosted either in a cloudbased or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients. The key components of FerriSmart are: - Specific Magnetic Resonance Imaging Protocol: Use of a specific magnetic resonance imaging protocol for acquisition of the raw image data. The imaging protocol is critical to ensure the quality of the end results. Its adherence is verified by the IQC Module, an automated algorithm that checks the correctness of the parameters of the data acquisition protocol. - FerriSmart AI Analysis Software: Custom-designed image analysis software performing the R2 measurement based on AI (Artificial Intelligence) technology. - An additional software module (algorithmic) that Liver Iron Measurement: incorporates a calibration curve relating R2 to liver iron concentration (LIC) is added to allow production of a liver iron concentration report. The result report provides the patient's average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.

The FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of non-transfusiondependent thalassemia patients receiving therapy with deferasirox.

The FerriScan R2-MRI Analysis System is a post-processing software tool that measures liver iron concentration based on the proton transverse relaxation rate (R2) of MRI images. R2 values are converted to liver iron concentration measurements using a calibration curve.