510(k) · Cleared
ClearedIqqa-Chest Software Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edda Technology, Inc. · OMJ Chest X-Ray Computer Aided Detection
Cleared on Oct 8, 2004 as substantially equivalent to K033374 (Siemens AG Medical Solutions, 2003) and 1 other predicate after a 35-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Oct 8, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- OMJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K913770 (1991). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 1 generation backK041380 Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc. · 2004
- This deviceK042408 Iqqa-Chest Software PackageEdda Technology, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −4 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −3 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −1 | K041380 | Imagechecker-CT Software Package with Filling Defect Indicator | R2 Technology, Inc. | 2004 | — |
| 0 (this device) | K042408 | Iqqa-Chest Software Package | Edda Technology, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033374 | Lungcare CT Software Package with Extended FunctionalitySummary page 1…F Device Number Date Siemens Medical LungCARE CT Software K033374 11/06/2003 Systems Package with extended functionalit R2 Technolog… | 2003 |
| * | K041380 | Imagechecker-CT Software Package with Filling Defect IndicatorSummary page 1…11/06/2003 Systems Package with extended functionalit R2 Technology ImageChecker CT K04 1380 06/08/2004 software package with __________________ FillingDefectIndicator 3. Indicat… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 4 other devices also cite its predicate K033374.
How does its category compare?
All OMJ devicesOMJ Chest X-Ray Computer Aided Detection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMJ
FDA has decided no OMJ device since 2007.
Median 510(k) review, days · OMJ
Too few OMJ 510(k)s in any year since 2007 to give a median.
Recalls per year · OMJ
No recall names OMJ since 2007.
Adverse event reports per year · OMJ
No MAUDE report names OMJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (103 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042408: Iqqa-Chest Software Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042408
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026