510(k) · Cleared
ClearedIqqa-Liver Multimodality Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edda Technology, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 25, 2013 as substantially equivalent to K041521 (General Electric Medical Systems, 2004) and 3 other predicates after a 62-day review. Its family tree reaches back 7 generations to 1996. 16 later devices descend from it.
- Decided
- Jul 25, 2013
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K954678 (1996). 15 ancestors in all, the oldest K871859 (1987). 16 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 3 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 2 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 1 generation backK082228 Planisight LinasysPathfinder Therapeutics, Inc. · 2008
- This deviceK131498 Iqqa-Liver Multimodality SoftwareEdda Technology, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- Descendant · cites it directly · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 3 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- Descendant · 4 generations on · 1 of its ownK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K141745Iqqa-Bodyimaging SoftwareEdda Technology · 2014 · cites it directly6descendants
- K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · cites it directly5descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 2 generations on4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 3 generations on3descendants
- K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −3 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −2 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −1 | K082228 | Planisight Linasys | Pathfinder Therapeutics, Inc. | 2008 | — |
| 0 (this device) | K131498 | Iqqa-Liver Multimodality Software | Edda Technology, Inc. | 2013 | — |
| +1 | K141745 | Iqqa-Bodyimaging Software | Edda Technology | 2014 | — |
| +1 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +2 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +3 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
| +4 | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 1…ance Number Date GE Medical Systems Volumec Viewer Plus K04 1521 06/22/2004 Mevis'Technology Mevis LiverAnialyser / LiverViewer K05 1528 07/20/2005 GMBH &… | 2004 |
| * | K051528 | Mevis Liveranalyser/Liverviewer SoftwareSummary page 1…ate GE Medical Systems Volumec Viewer Plus K04 1521 06/22/2004 Mevis'Technology Mevis LiverAnialyser / LiverViewer K05 1528 07/20/2005 GMBH & COKO Software _ ____ EDDA… | 2005 |
| * | K061696 | Iqqa-Liver SoftwareSummary page 1…GMBH & COKO Software _ ____ EDDA Technology IQQA-Liver Software (vi .0) K061696 11/13/2006 Pathfinder Therapeutics PlaniSighl Linasys K082228 09/22/2008 3. Indicat… | 2006 |
| * | K082228 | Planisight LinasysSummary page 1…_ EDDA Technology IQQA-Liver Software (vi .0) K061696 11/13/2006 Pathfinder Therapeutics PlaniSighl Linasys K082228 09/22/2008 3. Indications for Use (intended use): IQQA-Liver Multiniodality is a PC-based. selflcontained. non-invasi… | 2008 |
What descends from it? (16)
See all 164 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 17 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K141745 (Edda Technology, 2014) has gone furthest, with 6 descendants 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. 2013, 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-Liver Multimodality is a PC-based, self-contained, non-invasive image analysis software application for reviewing multiphase images derived from CT scanners and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation and reporting of liver and physician-identified lesions. The software supports a workflow based on automated image registration for viewing and analyzing…
Read the full statement (136 words)
IQQA-Liver Multimodality is a PC-based, self-contained, non-invasive image analysis software application for reviewing multiphase images derived from CT scanners and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation and reporting of liver and physician-identified lesions.
The software supports a workflow based on automated image registration for viewing and analyzing multiphase volume datasets. It 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, interactive definition of virtual resection plane, 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.
The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131498: Iqqa-Liver Multimodality Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131498
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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