510(k) · Cleared
ClearedUroNav (Version 2.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · LLZ System, Image Processing, Radiological
Cleared on Nov 16, 2015 as substantially equivalent to K081093 (Eigen, LLC, 2008) after a 25-day review. Its family tree reaches back 5 generations to 1996. 11 later devices descend from it.
- Decided
- Nov 16, 2015
- Review
- 25 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954678 (1996). 10 ancestors in all, the oldest K953259 (1995). 11 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- 1 generation backK081093 3-D Imaging WorkstationEigen, LLC · 2008
- This deviceK153073 UroNav (Version 2.0)Invivo Corporation · 2015
- Descendant · cites it directly · 3 of its ownK162474 ArtemisEigen · 2016
- Descendant · cites it directly · 2 of its ownK182561 UroNav (Version 3.0)Invivo Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK221499 Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK193403 UroNav SystemInvivo Corporation · 2019
- Descendant · cites it directly · 1 of its ownK173054 Navigo Workstation Version 2.0UC-CARE, Ltd. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K162474ArtemisEigen · 2016 · cites it directly3descendants
- K182561UroNav (Version 3.0)Invivo Corporation · 2018 · cites it directly2descendants
- K221499Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd. · 2022 · 2 generations on1descendant
- K193403UroNav SystemInvivo Corporation · 2019 · 2 generations on1descendant
- K173054Navigo Workstation Version 2.0UC-CARE, Ltd. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| −1 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| 0 (this device) | K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015 | — |
| +1 | K162474 | Artemis | Eigen | 2016 | — |
| +1 | K182561 | UroNav (Version 3.0) | Invivo Corporation | 2018 | — |
| +2 | K221499 | Minimally Invasive Prostate Surgery Navigation System | Augment Intelligent Medical System (China) Co., Ltd. | 2022 | — |
| +2 | K193403 | UroNav System | Invivo Corporation | 2019 | — |
| +1 | K173054 | Navigo Workstation Version 2.0 | UC-CARE, Ltd. | 2018 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K081093 | 3-D Imaging WorkstationSummary page 7…cate Device Information & Comparison Predicate Devices Name Predicate 510(k) Submission References 3-D Imaging Workstation K081093 (Primary) BioJet K122329 (Reference) PercuNav K121498 (Reference) The design, fun… | 2008 |
| † | K122329 | Biojet | 2012 |
| † | K121498 | Percunav | 2012 |
What descends from it? (11)
See all 115 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 19 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K162474 (Eigen, 2016) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K081093.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, gridplate…
Read the full statement (174 words)
UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, gridplate 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 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.
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/K153073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153073: UroNav (Version 2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153073
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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