| B554HEPATICA100 - Hepatica | 2021-02-22 Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the |
| B554LMS3400 - LiverMultiScan | 2021-02-15 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live |
| B554LMS3300 - LiverMultiScan | 2020-03-30 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live |
| B554LMS3200 - LiverMultiScan | 2020-01-21 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live |
| B554LMS3100 - LiverMultiScan | 2019-10-07 LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the traine |
| B554LMS2100 - LiverMultiScan | 2019-10-07 LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with |
| B554MRCP1000 - MRCP+ | 2019-10-07MRCP+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. |
| B554MRCP1000 - MRCP+ | 2019-10-07 MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary sy |
| B554LMS2000 - LiverMultiScan | 2018-07-06 LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with |