# K141745: Iqqa-Bodyimaging Software

- Pathway: 510(k) (Traditional)
- Applicant: Edda Technology
- Decided: Oct 31, 2014 after 123 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: 11 generations back to K913770 (1991). 53 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 60 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 4.
- K120484: Visia Oncology, MeVis Medical Solutions AG (2012) Summary page 4.
- K131498: Iqqa-Liver Multimodality Software, Edda Technology, Inc. (2013) Summary page 4.
- K113541: Clearstart SVM System, Intio, Inc. (2011) Summary page 4.

## Most influential descendants
- K191530: StoneChecker (2019), 1 descendant of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K240620: Cube Navigator (2024), 0 descendants of its own
- K202084: DeepLook PRECISE (2021), 0 descendants of its own
- K200315: Ziostation2 (2020), 0 descendants of its own

## Indications for use
IQQA-Bodylmaging is a PC-based, self-contained, non-invasive image analysis software application for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation, and reporting of body imaging studies and physician-identified lesions. The software supports a workflow based on automated image registration for viewing and analyzing multiphase and multiple time-point volume datasets. It includes tools for interactive segmentation and labeling of organ segments and vascular/ductal/airway structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane and virtual needle path, 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, monitoring, and follow-up. The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.

Source page: https://510kreport.com/device/K141745
Methodology: https://510kreport.com/methodology