# K131498: Iqqa-Liver Multimodality Software

- Pathway: 510(k) (Traditional)
- Applicant: Edda Technology, Inc.
- Decided: Jul 25, 2013 after 62 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: 7 generations back to K954678 (1996). 15 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 1.
- K051528: Mevis Liveranalyser/Liverviewer Software, Mevis Technology GmbH & Co. KG (2005) Summary page 1.
- K061696: Iqqa-Liver Software, Edda Technology, Inc. (2006) Summary page 1.
- K082228: Planisight Linasys, Pathfinder Therapeutics, Inc. (2008) Summary page 1.

## Most influential descendants
- K141745: Iqqa-Bodyimaging Software (2014), 6 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
IQQA-Liver Multimodality is a PC-based, self-contained, non-invasive image analysis software application for reviewing multiphase images derived from CT scanners and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation and reporting of liver and physician-identified lesions. The software supports a workflow based on automated image registration for viewing and analyzing multiphase volume datasets. It includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane, and allows for regional volumetric analysis of such lesions in terms of size, position, margin and enhancement pattern, providing information for physician's evaluation and treatment planning. The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.

Source page: https://510kreport.com/device/K131498
Methodology: https://510kreport.com/methodology