# K213960: LiverMultiScan v5 (LMSv5)

- Pathway: 510(k) (Traditional)
- Applicant: Perspectum
- Decided: Sep 6, 2022 after 263 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K971684 (1997). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202170: LiverMultiScan, Perspectum, Ltd. (2020) Summary page 4.
- K043271: R2-Mri Analysis System, Inner Vision Biometrics Pty, Ltd. (2005) Summary page 4.

## Most influential descendants
- K253413: LiverMultiScan (v6.0) (2026), 0 descendants of its own

## Indications for use
LiverMultiScan v5 (LMSv5) 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. LMSVS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMSVS provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K213960
Methodology: https://510kreport.com/methodology