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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.

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.