MRCP+ v1.0
Perspectum Diagnostics LtdMRCP+ v1.0 is a standalone software device from Perspectum Diagnostics that assists trained operators in the quantitative, non-invasive assessment of the biliary system using MR imaging data. It automatically generates 3D models of the biliary tree, measures bile duct widths, detects regions of variation, and provides tools for segmentation and volumetric analysis. This helps radiologists and clinicians better visualize and evaluate hepatobiliary structures, potentially improving diagnosis and patient care in biliary system diseases.
Intended Use
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, visualization and review of three-dimensional quantitative biliary system models and anatomical image data.
Technology
MRCP+v1 is a standalone software device that processes DICOM-compliant MRCP datasets to generate 3D biliary system models. It includes algorithmic tools for interactive segmentation, labeling, measurement of bile duct widths, automatic detection of regions of variation, and volumetric analysis of tree-like tubular structures and the gallbladder. It is designed for use on general purpose workstations and supports MRCP acquisition protocols from multiple MRI scanner vendors.
Performance
Performance testing includes bench validation using digital synthetic phantoms, clinical and tube width physical phantoms showing high algorithmic accuracy, precision, repeatability, and reproducibility of measurements. In-vivo testing on multiple 1.5T and 3T MRI scanners demonstrated consistent metrics across manufacturers and field strengths. Inter- and intra-operator variability were within acceptable limits, supporting safety and effectiveness. Compliance with IEC 62304, ISO 13485, and DICOM standard was confirmed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/13/2018
1 month - 2
FDA Approval
1/9/2019
Other devices from Perspectum Diagnostics Ltd
- LiverMultiScan (LMSv3)2019 • 510K
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