510(k) · Cleared
Cleared3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koelis · LLZ System, Image Processing, Radiological
Cleared on Jul 26, 2013 as substantially equivalent to K100793 (Koelis, 2010) after a 67-day review. Its family tree reaches back 6 generations to 1996. 6 later devices descend from it.
- Decided
- Jul 26, 2013
- Review
- 67 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 11 ancestors in all, the oldest K953259 (1995). 6 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- 2 generations backK081093 3-D Imaging WorkstationEigen, LLC · 2008
- 1 generation backK100793 Urostation 3D Prostate SuiteKoelis · 2010
- This deviceK131448 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option…Koelis · 2013
- Descendant · cites it directly · 2 of its ownK160934 UC-CARE NaviGo WorkstationUC-CARE, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK173054 Navigo Workstation Version 2.0UC-CARE, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK160357 TrinityKoelis · 2016
- Descendant · 3 generations on · 0 of its ownK250664 Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK170521 Trinity/3D Prostate SuiteKoelis · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160934UC-CARE NaviGo WorkstationUC-CARE, Ltd. · 2017 · cites it directly2descendants
- K173054Navigo Workstation Version 2.0UC-CARE, Ltd. · 2018 · 2 generations on1descendant
- K160357TrinityKoelis · 2016 · cites it directly1descendant
- K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd. · 2025 · 3 generations on0descendants
- K170521Trinity/3D Prostate SuiteKoelis · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| −2 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| −1 | K100793 | Urostation 3D Prostate Suite | Koelis | 2010 | — |
| 0 (this device) | K131448 | 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second… | Koelis | 2013 | — |
| +1 | K160934 | UC-CARE NaviGo Workstation | UC-CARE, Ltd. | 2017 | — |
| +2 | K173054 | Navigo Workstation Version 2.0 | UC-CARE, Ltd. | 2018 | — |
| +1 | K160357 | Trinity | Koelis | 2016 | — |
| +3 | K250664 | Navigo Workstation 2.3 (FPRMC00039) | UC-CARE, Ltd. | 2025 | — |
| +2 | K170521 | Trinity/3D Prostate Suite | Koelis | 2017 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K100793 | Urostation 3D Prostate SuiteSummary page 4…RUS FUSIO mapping OPTION OPTION 510(k) number: K100793 ___________________ -20/3D image:… | 2010 |
What descends from it? (6)
3 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 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K160934 (UC-CARE, Ltd., 2017) has gone furthest, with 2 descendants of its own.
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?
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multi-planar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D image registration and data reporting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131448
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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