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Intended Use

LiverMultiScan v5 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 v5 is a standalone post-processing software that uses DICOM 3.0 compliant MR image datasets from compatible MR systems to display the internal structure of the abdomen including automated liver segmentation and region of interest placements. It quantifies liver tissue metrics such as PDFF, T2*, LIC, and iron corrected T1 (cT1) using machine learning for artifact detection and segmentation, generating parametric maps and a quantifiable report for clinical interpretation.

Performance

Software verification and validation were conducted according to FDA guidance with moderate software level of concern. Bench testing included functional verification of installation, licensing and feature functionality. Accuracy and precision were assessed using phantoms and in-vivo volunteer data. Inter and intra-operator variability was evaluated. Overall performance testing demonstrated that LiverMultiScan v5 is at least as safe and effective as predicate devices.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/17/2021

    8 months
  • 2

    FDA Approval

    9/6/2022

Other devices from Perspectum

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