# K172685: LiverMultiScan

- Pathway: 510(k) (Traditional)
- Applicant: Perspectum Diagnostics, Ltd.
- Decided: Nov 21, 2017 after 76 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: 12 generations back to K971684 (1997). 34 ancestors in all.
7 later devices descend from it; 1 cites it directly.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143020: LiverMultiScan, Mirada Medical, Ltd. (2015) Summary page 4.

## Most influential descendants
- K190017: LiverMultiScan (LMSv3) (2019), 6 descendants of its own
- K202170: LiverMultiScan (2020), 3 descendants of its own
- K213960: LiverMultiScan v5 (LMSv5) (2022), 1 descendant of its own
- K212565: CoverScan v1 (2022), 1 descendant of its own
- K253413: LiverMultiScan (v6.0) (2026), 0 descendants of its own

## Indications for use
LiverMultiScan (LMSv2) 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. LiverMultiScan (LMSv2) 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. LiverMultiScan (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 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/K172685
Methodology: https://510kreport.com/methodology