510(k) · Cleared
ClearedNavigo Workstation 2.3 (FPRMC00039)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
UC-CARE, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 7, 2025 as substantially equivalent to K173054 (UC-CARE, Ltd., 2018) after a 155-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Aug 7, 2025
- Review
- 155 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954678 (1996). 16 ancestors in all, the oldest K953259 (1995). No later device cites it as a predicate yet.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK131448 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option…Koelis · 2013
- 2 generations backK160934 UC-CARE NaviGo WorkstationUC-CARE, Ltd. · 2017
- 1 generation backK173054 Navigo Workstation Version 2.0UC-CARE, Ltd. · 2018
- This deviceK250664 Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- 5 generations backK081093 3-D Imaging WorkstationEigen, LLC · 2008
- 4 generations backK100793 Urostation 3D Prostate SuiteKoelis · 2010
- 3 generations backK131448 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option…Koelis · 2013
- 2 generations backK160934 UC-CARE NaviGo WorkstationUC-CARE, Ltd. · 2017
- 1 generation backK173054 Navigo Workstation Version 2.0UC-CARE, Ltd. · 2018
- This deviceK250664 Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| −5 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| −4 | K100793 | Urostation 3D Prostate Suite | Koelis | 2010 | — |
| −3 | K131448 | 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second… | Koelis | 2013 | — |
| −2 | K160934 | UC-CARE NaviGo Workstation | UC-CARE, Ltd. | 2017 | — |
| −1 | K173054 | Navigo Workstation Version 2.0 | UC-CARE, Ltd. | 2018 | — |
| 0 (this device) | K250664 | Navigo Workstation 2.3 (FPRMC00039) | UC-CARE, Ltd. | 2025 | — |
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 |
| 2011 | 1 | 0 |
| 2015 | 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.
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 16 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and 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. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other. It also provides the ability to display a…
Read the full statement (216 words)
The UC-Care Navigo Workstation is an adjunctive tool for ultrasound guided procedures and 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. The Navigo Workstation offers the ability to fuse DICOM originated information (e.g. MRI, CT) with the ultrasound images and thus superimposes information from one modality onto the other.
It also provides the ability to display a simulated image of a tracked insertion tool such as a needle, guide wire, catheter, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement.
Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration, as well as storage and future retrieval of this information.
Navigo is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. The software is not intended to predict ablation volumes or predict ablation success.
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/K250664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250664: Navigo Workstation 2.3 (FPRMC00039).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250664
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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