DEVICE: FerriSmart (09369998038619)

Device Description: 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 (R2) 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 cloud-based 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 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. 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 and patients with sickle cell disease receiving blood transfusions • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.