510(k) · Cleared
Cleared3-D Imaging Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eigen, LLC · LLZ System, Image Processing, Radiological
Cleared on May 1, 2008 as substantially equivalent to K063107 (Biotronics3D, Ltd., 2006) and 1 other predicate after a 14-day review. Its family tree reaches back 4 generations to 1996. 31 later devices descend from it.
- Decided
- May 1, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954678 (1996). 9 ancestors in all, the oldest K953259 (1995). 31 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- This deviceK081093 3-D Imaging WorkstationEigen, LLC · 2008
- Descendant · cites it directly · 11 of its ownK153073 UroNav (Version 2.0)Invivo Corporation · 2015
- Descendant · cites it directly · 8 of its ownK093672 Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK100793 Urostation 3D Prostate SuiteKoelis · 2010
- Descendant · 2 generations on · 6 of its ownK131448 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option…Koelis · 2013
- Descendant · 2 generations on · 4 of its ownK120187 Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K153073UroNav (Version 2.0)Invivo Corporation · 2015 · cites it directly11descendants
- K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009 · cites it directly8descendants
- K100793Urostation 3D Prostate SuiteKoelis · 2010 · cites it directly7descendants
- K1314483D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Koelis · 2013 · 2 generations on6descendants
- K120187Multi-Modality Image FusionIgt, LLC Dba Eigen · 2012 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| 0 (this device) | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| +1 | K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015 | — |
| +1 | K093672 | Aegis Navigation Anda Egis Pelvic Application | Sentinelle Medical, Inc. | 2009 | — |
| +1 | K100793 | Urostation 3D Prostate Suite | Koelis | 2010 | — |
| +2 | K131448 | 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second… | Koelis | 2013 | — |
| +2 | K120187 | Multi-Modality Image Fusion | Igt, LLC Dba Eigen | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K063107 | 3DNET SuiteSummary page 1…R 892.2050 Predicate Devices: Device Name -5 10(k) Number 3-Dnet Suite K063 107 XELERIS 2 Processing and K05 1673 Review Work… | 2006 |
| * | K051673 | Xeleris 2 Processing and Review WorkstationSummary page 1…-5 10(k) Number 3-Dnet Suite K063 107 XELERIS 2 Processing and K05 1673 Review Workstation Description of the Device and Summary of the Technological Chara… | 2005 |
What descends from it? (31)
See all 319 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153073 | UroNav (Version 2.0) | 2015 | 11 |
| K093672 | Aegis Navigation Anda Egis Pelvic Application | 2009 | 8 |
| K100793 | Urostation 3D Prostate Suite | 2010 | 7 |
| K162474 | Artemis | 2016 | 3 |
| K100784 | UC-Care Navigo Sytem | 2011 | 3 |
| K153166 | Fusion Bx | 2016 | 1 |
| K222222 | Artemis, Artemis TPO, Artemis MX | 2023 | 0 |
| K222683 | Fibroid Mapping Reviewer Application (FMRA) | 2023 | 0 |
| K122329 | Biojet | 2012 | 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 12 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K153073 (Invivo Corporation, 2015) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K063107.
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?
The 3-D Imaging Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081093: 3-D Imaging Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081093
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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