# K061696: Iqqa-Liver Software

- Pathway: 510(k) (Traditional)
- Applicant: Edda Technology, Inc.
- Decided: Nov 13, 2006 after 152 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: 5 generations back to K954678 (1996). 13 ancestors in all.
217 later devices descend from it; 7 cite it directly.
1 of 231 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051528: Mevis Liveranalyser/Liverviewer Software, Mevis Technology GmbH & Co. KG (2005) Summary page 1.
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 2.

## Most influential descendants
- K071310: Syngo CT Oncology Software Package (2007), 195 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 descendants of its own

## Indications for use
The IQQA-Liver is a PC-based, self-contained, non-invasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions. The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also 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, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization. The software is designed for use by trained physicians. Image source: DICOM.

Source page: https://510kreport.com/device/K061696
Methodology: https://510kreport.com/methodology