# K143020: LiverMultiScan

- Pathway: 510(k) (Traditional)
- Applicant: Mirada Medical, Ltd.
- Decided: Jun 23, 2015 after 246 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: 11 generations back to K971684 (1997). 33 ancestors in all.
8 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)
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel, Siemens Medical Solutions USA, Inc. (2014). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K172685: LiverMultiScan (2017), 7 descendants of its own
- 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

## Indications for use
F_MS is indicated for use as 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 LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows. These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K143020
Methodology: https://510kreport.com/methodology