510(k) · Cleared
ClearedFiatlux Visualize
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiatlux Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 1, 2008 as substantially equivalent to K063470 (Aycan Digitalsysteme GmbH, 2007) and 1 other predicate after a 14-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Aug 1, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K942120 (1994). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 6 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 5 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 4 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 3 generations backK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- 2 generations backK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- 1 generation backK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- This deviceK082041 Fiatlux VisualizeFiatlux Imaging, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK090295 Bodyviz, Model 100Visual Medical Solutions, LLC · 2009
Most influential descendants
Showing 1 of 1 · See all- K090295Bodyviz, Model 100Visual Medical Solutions, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −6 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −5 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −4 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −3 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| −2 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| −1 | K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | 2007 | — |
| 0 (this device) | K082041 | Fiatlux Visualize | Fiatlux Imaging, Inc. | 2008 | — |
| +1 | K090295 | Bodyviz, Model 100 | Visual Medical Solutions, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K063470 | Aycan Workstation OsirixSummary page 1…ces FiatLux Imaging believes that FiatLux VisualizeTM is substantially equivalent to other commercially available products, specifically: * aycan Workstation OsiriX (K063470) • BarcoView Voxar 3D (KO60505) Device Description FiatLux Visualize TM is a medical device software application that provide… | 2007 |
| * | K060505 | Voxar 3D Enterprise, Model 6.1 | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090295 | Bodyviz, Model 100 | 2009 | 0 |
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 14 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K090295 (Visual Medical Solutions, LLC, 2009) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K063470.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
FiatLux Visualize TM is a medical diagnosis software application that allows
physicians, radiologists, medical technicians, nurses, and other trained medical
professionals to select, review and analyze DICOM images acquired from CT
and MR devices. It provides a suite of tools for 2D/3D reconstruction based on
the input image dataset.
FiatLux VisualizeTM software must be installed on a suitable commercial
computer platform. It is the user's responsibility to ensure the monitor quality and
ambient light conditions are consistent with the clinical applications.
Mammographic and compressed images are not supported for viewing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082041: Fiatlux Visualize.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082041
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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