LiverMultiScan
Perspectum LTDLiverMultiScan (LMSv4) is a standalone software device that assists clinicians by processing MR images of the liver to provide quantitative maps and measurements that help characterize liver tissue health. It automates segmentation and analysis of MRI data to produce reports for trained clinicians to interpret as part of liver disease diagnosis and assessment.
Intended Use
LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
Technology
LiverMultiScan is a standalone post-processing software that takes DICOM 3.0 compliant MR image datasets from compatible MRI systems and provides automated liver segmentation, ROI placement, and quantitative assessments including proton density fat fraction (PDFF), T2*, and iron-corrected T1 (cT1) parametric maps.
Performance
Performance testing demonstrated accuracy and precision of LMSv4 metrics (cT1, T2*, PDFF) using phantoms and in-vivo volunteer data across different scanners and field strengths. Measurements showed high repeatability and reproducibility within prescribed criteria. No clinical investigations were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/3/2020
2 months - 2
FDA Approval
10/2/2020
Other devices from Perspectum LTD
- VitruvianScan (v1.0)2024 • 510K
- LiverMultiScan v5 (LMSv5)2022 • 510K
- Hepatica v1 (Hepatica v1.0.0)2021 • 510K
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