510(k) · Cleared
ClearedIqqa-Bodyimaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edda Technology · LLZ System, Image Processing, Radiological
Cleared on Oct 31, 2014 as substantially equivalent to K041521 (General Electric Medical Systems, 2004) and 3 other predicates after a 123-day review. Its family tree reaches back 11 generations to 1991. 6 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 123 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K913770 (1991). 53 ancestors in all, the oldest K871859 (1987). 6 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK120484 Visia OncologyMeVis Medical Solutions AG · 2012
- This deviceK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- Descendant · cites it directly · 1 of its ownK191530 StoneCheckerImaging Biometrics, LLC · 2019
- Descendant · cites it directly · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK240620 Cube NavigatorMedical Templates AG · 2024
- Descendant · 2 generations on · 0 of its ownK202084 DeepLook PRECISEDeeplook, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK120484 Visia OncologyMeVis Medical Solutions AG · 2012
- This deviceK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191530StoneCheckerImaging Biometrics, LLC · 2019 · cites it directly1descendant
- K181892Ziostation2Ziosoft, Inc. · 2018 · cites it directly1descendant
- K240620Cube NavigatorMedical Templates AG · 2024 · cites it directly0descendants
- K202084DeepLook PRECISEDeeplook, Inc. · 2021 · 2 generations on0descendants
- K200315Ziostation2Ziosoft, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −2 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −1 | K120484 | Visia Oncology | MeVis Medical Solutions AG | 2012 | — |
| 0 (this device) | K141745 | Iqqa-Bodyimaging Software | Edda Technology | 2014 | — |
| +1 | K191530 | StoneChecker | Imaging Biometrics, LLC | 2019 | — |
| +1 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +1 | K240620 | Cube Navigator | Medical Templates AG | 2024 | — |
| +2 | K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021 | — |
| +2 | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K041521 | Volume Viewer PlusSummary page 4…Number Clearance Date GE Medical Systems Volume Viewer Plus K041521 06/22/2004 Mevis Medical Solutions Visia Oncology K120484 03/27/2012 EDDA Technology… | 2004 |
| * | K120484 | Visia OncologySummary page 4…ate GE Medical Systems Volume Viewer Plus K041521 06/22/2004 Mevis Medical Solutions Visia Oncology K120484 03/27/2012 EDDA Technology IQQA-Liver Multimodality K131498 07/25/2013 Intio… | 2012 |
| * | K131498 | Iqqa-Liver Multimodality SoftwareSummary page 4…004 Mevis Medical Solutions Visia Oncology K120484 03/27/2012 EDDA Technology IQQA-Liver Multimodality K131498 07/25/2013 Intio ClearStart SVM K113541 12/16/2011 3. Indications… | 2013 |
| * | K113541 | Clearstart SVM SystemSummary page 4…012 EDDA Technology IQQA-Liver Multimodality K131498 07/25/2013 Intio ClearStart SVM K113541 12/16/2011 3. Indications for Use (intended use): IQQA-BodyImaging is a PC-based, self-contained, non-invasive image… | 2011 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 13 of the 53 ancestors have a recall of any class.
- Of its descendants, K191530 (Imaging Biometrics, LLC, 2019) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K041521.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (152 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141745: Iqqa-Bodyimaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141745
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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