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VitruvianScan is indicated for use as a magnetic resonance diagnostic device software application for non-invasive fat and muscle evaluation that enables the generation, display and review of magnetic resonance medical image data. VitruvianScan produces quantified metrics and composite images from magnetic resonance medical image data which when interpreted by a trained healthcare professional, yield information that may assist in clinical decisions.

VitruvianScan is a standalone, post processing software medical device. VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit). When a referring healthcare professional requests quantitative analysis using VitruvianScan, relevant images are acquired from patients at MRI scanning clinics and are transferred to the Perspectum portal through established secure gateways. Perspectum trained analysts use the VitruvianScan 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. The metrics produced by VitruvianScan are intended to provide insight into the composition of muscle and fat of a patient. The device is intended to be used as part of an overall assessment of a patient's health and wellness and should be interpreted whilst considering the device's limitations when reviewing or interpreting images.

MRCP+ v2 is indicated for use as a software-based image processing system for noninvasive, quantitative assessment of biliary system structures. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable the measurement of bile duct widths and quantification of strictures and dilatations. MRCP+ v2 includes tools for interactive segmentation and labelling of the biliary system, including the gallbladder. MRCP+ v2 provides metrics for interpretation by trained physicians to assist in the assessment of the biliary system. These metrics support physicians in the visualization, evaluation and reporting of hepatobiliary structures. MRCP+ v2 is designed to utilize DICOM-compliant MRCP datasets acquired on supported MR scanners using supported MRCP acquisition protocols.

MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the quantitative evaluation of biliary system structures acquired from magnetic resonance (MR) images from a single time-point (a patient visit). A Perspectum-trained operator loads previously acquired magnetic resonance cholangiopancreatography (MRCP) data as input into the MRCP+ v2 device. A structured summary report is generated as output by the device, which includes quantitative analysis results and geometric characteristics of the biliary system and pancreatic ducts. The MRCP+ v2 report is intended to facilitate reporting by a radiologist for subsequent interpretation and to aid diagnosis by a physician as part of a panel of testing, including conventional radiological tools. MRCP+ v2 is designed to utilize Digital Imaging and Communications in Medicine (DICOM)-compliant MRCP datasets acquired on supported MR scanners to display the fluid-filled tubular structures in the abdomen, including intra- and extra-hepatic biliary tree, gallbladder, and pancreatic duct system. Analysis and evaluation tools in MRCP+ v2 include segmentation of structures utilizing user input of seeding points, interactive labelling of segmented areas, and quantitative measurement derived from segmentation results. MRCP+ v2 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation in the width of tubular structures, including those quantified as strictures and dilations. MRCP+ v2 includes tools allowing for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.

CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of DICOM compliant medical images and MR data. CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time (T1, srT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration). These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients. CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and Siemens 3T MRI scanners.

CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen. Metrics produced by CoverScan can be used by healthcare professionals (HCPs) in a clinical setting for the purposes of assessing multiple organs. CoverScan v1.1 is a new version of CoverScan that supports the use of Siemens 3T scan data to enable more scan sites to utilise CoverScan.

LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

LiverMultiScan v5 (LMSv5) is a standalone software device. The LiverMultiScan v5 device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit). LiverMultiScan is a post-processing software device, a trained operator uses tools within the device interface to quantify liver tissue characteristics from parametric maps. LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver. A summary report from the analysis conducted is generated for interpretation by a clinician. LiverMultiScan v5 is not intended to replace the established procedures for the assessment of a patient's liver health by a clinician, providing many opportunities for competent human intervention in the clinical care of patients. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of clinical care, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan v5 metrics, may contribute to a diagnostic decision. LiverMultiScan v5 is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan v5 is an aid to diagnosis and treatment decisions remain the responsibility of the clinician.

CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data. CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney. CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration). These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients. CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.

CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen. Metrics produced by CoverScan can be used by licensed physicians in a clinical setting for the purposes of assessing multiple organs.

Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health. Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health. Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.

Hepatica v1 is a standalone software device that imports MR datasets encompassing the abdomen, including the liver. Visualisation and display of T1-weighted MR data which can be analysed, and quantitative metrics of tissue characteristics and liver volume are then reported. Datasets imported into Hepatica are DICOM 3.0 compliant and reported metrics are independent of the MRI equipment vendor. It allows for the 3D visualisation of the liver and quantification of metrics (cT1, PDFF and volumetry) from liver tissue and exportation of results and images to a deliverable report. Hepatica v1 supports semi-automatic liver segmentation of T1-weighted volumetric data. Liver segmentation in Hepatica v1 requires the placement of anatomical landmarks to define the outer contours of the liver and can be adjusted by the operator, where necessary. Where available, whole liver and segmental cT1 and PDFF quantitative metrics derived from the predicate device may be presented in the final report. Hepatica uses volumetric datasets to create 2D anatomical views from all supported scanners. Where available, cT1 and PDFF parametric maps are derived from the predicate device. Quantified metrics and images derived from the analysis of liver volume and tissue characteristics are collated into a report for evaluation and interpretation by a clinician.

LiverMultiScan (LMSv4) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv4) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv4) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessments of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may be optionally computed using the DIXON or LMS MOST methods. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit). LiverMultiScan is a post-processing software device, a trained operator uses tools such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is subsequently sent to an interpreting clinician at the acquiring site. LiverMultiScan is not intended to replace the established procedures for the assessment of a patient's liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation. Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics is to provide imaging information to assist in characterizing tissue in the liver, in addition to existing methods for obtaining information relating to the liver. LiverMultiScan metrics are not intended to replace any existing diagnostic source of information but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. LiverMultiScan is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan is an aid to diagnosis and treatment decisions remains the responsibility of the clinician. In consequence, the product is considered to have no adverse effect on health since the results represent only a part of the information that the user will utilize for final interpretation. In this regard, LiverMultiScan presents a moderate level of concern with respect to patient safety.

LiverMultiScan (LMSv3) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

LiverMultiScan (LMSv3) is a standalone software application for displaying 2D Magnetic Resonance (MR) medical image data acquired from compatible MR Scanners. LiverMultiScan runs on general-purpose workstations with a colour monitor, keyboard and mouse. The main functionality of LiverMultiScan (LMSv3) includes: - Reading DICOM 3.0 compliant datasets stored on workstations, and display of the data acquisition information - Post-processing of MRI data to generate parametric maps of Proton Density Fat Fraction PDFF), T2*, T1 and ironcorrected T1 (cT1) of the liver. - Quantification, and calculation of PDFF, T2* and cT1 metrics using tools such as automatic liver segmentation and ROI (region of interest) placement. - Generation of a summary report demonstrating the quantitative assessment results of fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1).

MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data. MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder. Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment. MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols. MRCP+v1 is suitable for all patients not contra-indicated for MRI.

MRCP+v1 is a standalone software device. The purpose of the MRCP+v1 device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator, typically a radiographer or technician trained in radiological anatomy, loads as input into the MRCP+v1 device previously acquired MRCP data. The device is intended to be used by a trained operator to generate metrics in the form of a summary report to enable reporting by a radiologist for subsequent interpretation and diagnosis by a clinician. MRCP+v1 is designed to utilize DICOM 3.0 compliant MRCP datasets, acquired on supported MR scanners, to display the fluid-filled tubular structures in the abdomen, including the intra- and extrahepatic biliary tree, gallbladder and pancreatic ductal system. Analysis and evaluation tools include: - Segmentation of structures utilising user input of seeding points. - Interactive labelling of segmented areas. - Quantitative measurement derived from segmentation and labelling results. MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder. The radiologist may use existing radiological tools to report on the biliary tree. The reviewing radiologist needs to take into consideration the device's limitations and accuracy during review. The MRCP+v1 report is intended to supplement a conventional radiology report, for interpretation by a clinician. MRCP+v1 does not replace the usual procedures for assessment of the biliary system by a reviewing radiologist or interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional input to radiologists and clinicians in addition to that provided by conventional MRCP.

LiverMultiScan (LMSv2) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv2) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

LiverMultiScan (LMSv2) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from compatible MR Scanners. LiverMultiScan runs on a general purpose workstation with a colour monitor, keyboard and mouse. LiverMultiScan (LMSv2) is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the operator may also create, display, print, store and distribute reports resulting from interpretation of the datasets. LiverMultiScan (LMSv2) allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements. LiverMultiScan (LMSv2) provides a number of tools, such as circular region of interest placements, to be used for the assessment of regions of an image to support a clinical workflow. LiverMultiScan (LMSv2) allows the operator to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat. LiverMultiScan (LMSv2) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to radiologists, gastroenterologists, and hepatologists. LiverMultiScan (LMSv2) is an aid to diagnosis. When interpreted by a trained clinician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows. LiverMultiScan (LMSv2) offers the following. - Advanced visualisation of MR data. - Processing of MR data to quantify tissue characteristics including MR relaxivity constants such as T2*, T1, ironcorrected T1 (cT1) and triglyceride fat fraction (expressed as liver fat percentage). - Circular region of interest statistics. - Snapshot of images to include in a report. - Report to include region statistics, snapshot images and user-entered text. - Export of snapshot images to report.