# K201092: LSN

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Biometrics, LLC
- Decided: Oct 29, 2020 after 189 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942120 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133649: Hepatic Vcar, GE Medical Systems SCS (2014) Summary page 4.
- K101342: Osirix MD, Pixmeo Sarl (2010) Summary page 4.

## Indications for use
LSN (Liver Surface Nodularity) is an image analysis software application intended to assist radiologists and other trained healthcare professionals in analyzing and reporting on the liver morphology depicted in computed tomography (CT) images for use in assessment of chronic liver disease. LSN is designed to assist the user in the evaluation and documentation of liver morphology, specifically liver surface nodularity, provided that the surface nodularity is adequately depicted on the CT images. LSN provides quantitative metrics related to liver fibrosis by automating segmentation of the liver surface within user-defined Regions of Interest (ROIs) and calculating distances and means related to the liver surface nodularity. LSN also offers reporting capabilities for documenting user-confirmed results, thereby facilitating communication with other trained healthcare professionals and assessment of changes over time. LSN is intended to provide image-related information that is interpreted by a trained professional, but it does not directly generate any diagnosis. The information provided by LSN should not be used in isolation when making patient management decisions. LSN is not intended for use with or for the diagnostic interpretation of mammography images.

Source page: https://510kreport.com/device/K201092
Methodology: https://510kreport.com/methodology