# K253413: LiverMultiScan (v6.0)

- Pathway: 510(k) (Traditional)
- Applicant: Perspectum, Ltd.
- Decided: Mar 9, 2026 after 159 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: 16 generations back to K971684 (1997). 43 ancestors in all.
No later device cites it as a predicate yet.
3 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213960: LiverMultiScan v5 (LMSv5), Perspectum (2022) Summary page 5.

## Indications for use
The device is indicated for use as a magnetic resonance diagnostic device software application for non-invasive assessment of liver health and the generation, display and review of magnetic resonance medical image data. The device produces quantified metrics and composite images from magnetic resonance medical image data which, when interpreted by a trained healthcare professional, yield information on liver tissue characteristics that may assist in clinical decisions.

Source page: https://510kreport.com/device/K253413
Methodology: https://510kreport.com/methodology