# K071241: LMS-Liver

- Pathway: 510(k) (Traditional)
- Applicant: Median Technologies
- Decided: Jun 8, 2007 after 36 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K945512 (1995). 45 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061671: Syngo Trued, Model VC10A, Siemens Medical Solutions (2006) Summary page 2.
- K053301: Cedara I-Response Cedara Pet/CT, Cedara Software Corp. (2006) Summary page 2.

## Most influential descendants
- K121213: Vitreaadvanced (2012), 8 descendants of its own
- K142521: Synapse 3D Liver and Kidney Analysis (2014), 5 descendants of its own
- K151988: Visible Patient Suite (2015), 4 descendants of its own
- K212896: Visible Patient Suite (2021), 3 descendants of its own
- K250237: InferOperate Suite (2025), 1 descendant of its own

## Indications for use
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images. LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.

Source page: https://510kreport.com/device/K071241
Methodology: https://510kreport.com/methodology