LiverMultiScan (LMSv3)
Perspectum Diagnostics LtdLiverMultiScan (LMSv3) is a software tool that helps clinicians analyze liver MRI scans. It produces detailed images and quantitative maps of liver tissue properties such as fat content, iron levels, and T1 relaxation times to assist in non-invasive liver evaluation. This software aids trained operators in generating reports that help medical professionals diagnose liver diseases more accurately and efficiently.
Intended Use
LiverMultiScan (LMSv3) 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. Provides automated liver segmentation and quantification of triglyceride fat fraction, T2*, and iron-corrected T1 (cT1).
Technology
Standalone software application that processes DICOM 3.0 compliant MRI datasets from compatible MR systems. Generates parametric maps of PDFF, T2*, T1, and iron-corrected T1 of the liver. Provides tools for automated liver segmentation and region of interest placement to enable quantitative assessment. Produces summary reports with quantitative metrics for clinical diagnosis.
Performance
Performance testing included phantom and in-vivo clinical testing, demonstrating accuracy, repeatability, and reproducibility of liver tissue metrics (cT1, T2*, PDFF). Comparisons with a predicate device LMSv2 show substantial equivalence. The device meets IEC 62304, IEC 62366, ISO 14971, ISO 13485 standards for software and safety. Validation was conducted per FDA requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/3/2019
5 months - 2
FDA Approval
6/27/2019
Other devices from Perspectum Diagnostics Ltd
- MRCP+ v1.02019 • 510K
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