# K042408: Iqqa-Chest Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Edda Technology, Inc.
- Decided: Oct 8, 2004 after 35 days
- Product code: OMJ (Chest X-Ray Computer Aided Detection)
- 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: 6 generations back to K913770 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033374: Lungcare CT Software Package with Extended Functionality, Siemens AG Medical Solutions (2003) Summary page 1.
- K041380: Imagechecker-CT Software Package with Filling Defect Indicator, R2 Technology, Inc. (2004) Summary page 1.

## Indications for use
The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysis package used during the review of digital chest radiographic images. Combining image viewing, evaluation and reporting tools, the software is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the confirmation, evaluation and documentation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation for the visual identification of possible lesions. The tools also allow for regional analysis of possible lesions in terms of size, shape and position, thus aiding the physician in the characterization of physician-identified suspicious lesions. Image source: DICOM

Source page: https://510kreport.com/device/K042408
Methodology: https://510kreport.com/methodology