510(k) · Cleared
ClearedUroNav 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips DS North America, LLC · LLZ System, Image Processing, Radiological
Cleared on Jun 5, 2025 as substantially equivalent to K193403 (Invivo Corporation, 2019) after an 83-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jun 5, 2025
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 13 ancestors in all, the oldest K953259 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- 4 generations backK081093 3-D Imaging WorkstationEigen, LLC · 2008
- 3 generations backK153073 UroNav (Version 2.0)Invivo Corporation · 2015
- 2 generations backK182561 UroNav (Version 3.0)Invivo Corporation · 2018
- 1 generation backK193403 UroNav SystemInvivo Corporation · 2019
- This deviceK250800 UroNav 4Philips DS North America, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| −4 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| −3 | K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015 | — |
| −2 | K182561 | UroNav (Version 3.0) | Invivo Corporation | 2018 | — |
| −1 | K193403 | UroNav System | Invivo Corporation | 2019 | — |
| 0 (this device) | K250800 | UroNav 4 | Philips DS North America, LLC | 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 |
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 |
|---|---|---|---|
| * | K193403 | UroNav SystemSummary page 6…ystem, Image Processing, Radiological Classification Regulation: 21 CFR 892.2050 Classification Panel: Radiology Device Class: Class II Product code: LLZ 510(k) Clearance: K193403, December 27th, 2019. Premarket Notification [510(k)] Submission Philips DS North America LLC.… | 2019 |
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 2.9 years on median.
- 2 of the 13 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?
UroNav is a stereotaxic medical device intended to assist the clinician with planning and guidance for clinical, interventional and/or diagnostic procedures for biopsy and/or soft tissue ablation. It provides 2D and 3D visualization of Ultrasound (U/S) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR). It also provides the ability to display a simulated image of a tracked…
Read the full statement (163 words)
UroNav is a stereotaxic medical device intended to assist the clinician with planning and guidance
for clinical, interventional and/or diagnostic procedures for biopsy and/or soft tissue ablation.
It provides 2D and 3D visualization of Ultrasound (U/S) images and the ability to fuse and register
these images with those from other imaging modalities such as Magnetic Resonance (MR).
It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy
needle, guidewire, 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.
Other software features include patient data management, multi-planar reconstruction,
segmentation, image measurements and 2D/3D image registration. UroNav is indicated for medical
conditions that require interventional and/or diagnostic procedures of the prostate gland.
The software is not intended for diagnosis. 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/K250800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250800: UroNav 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250800
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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