DEVICE: CoverScan (B554CSMD1200)

Device Description: CoverScanMD is a standalone, post-processing software as a medical device (SaMD) specifically designed for the processing and analysis of magnetic resonance imaging (MRI) data. It enables the visualisation, analysis and generation of quantitative metrics and composite images from MRI scans. CoverScanMD consists of MultiScan software and a data consolidation software which reads results from compatible SaMD's that are independently authorised for use as medical devices. The data consolidation software compiles all the input data (metrics and image references) and produces a single JSON file output which are then used to generate quantitative multi-parametric MRI reports. The data consolidation software does not modify any input data, instead, it just appends all data into one single JSON file and a list of associated images for report generation. The report generation is done outside the CoverScanMD medical device and hence does not form part of the CoverScanMD medical device. When a referring healthcare professional requests quantitative analysis using CoverScanMD, relevant images are acquired from patients using a single MRI scan at the MR clinic and are transferred to the Perspectum Portal through established secure gateways. Perspectum trained operators use the CoverScanMD software medical device to process the MRI images and produce the quantitative metrics and composite images. The device output information is then sent to the healthcare professionals for their clinical use. CoverScanMD is only used within Perspectum’s secure infrastructure by trained operators to process clinical images and generate metrics. The metrics and composite images output by CoverScanMD are then sent to trained Healthcare Professionals who then interpret the information to make informed decisions.