510(k) · Cleared
Cleared3DNET Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronics3D, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Oct 27, 2006 as substantially equivalent to K963697 (Bio-Vascular, Inc., 1996) and 1 other predicate after a 16-day review. Its family tree reaches back 3 generations to 1996. 34 later devices descend from it.
- Decided
- Oct 27, 2006
- Review
- 16 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954678 (1996). 5 ancestors in all, the oldest K953259 (1995). 34 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- This deviceK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- Descendant · cites it directly · 31 of its ownK081093 3-D Imaging WorkstationEigen, LLC · 2008
- Descendant · 2 generations on · 11 of its ownK153073 UroNav (Version 2.0)Invivo Corporation · 2015
- Descendant · 2 generations on · 8 of its ownK093672 Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK100793 Urostation 3D Prostate SuiteKoelis · 2010
- Descendant · 3 generations on · 6 of its ownK131448 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option…Koelis · 2013
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K0810933-D Imaging WorkstationEigen, LLC · 2008 · cites it directly31descendants
- K153073UroNav (Version 2.0)Invivo Corporation · 2015 · 2 generations on11descendants
- K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009 · 2 generations on8descendants
- K100793Urostation 3D Prostate SuiteKoelis · 2010 · 2 generations on7descendants
- K1314483D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Koelis · 2013 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −2 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| 0 (this device) | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| +1 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| +2 | K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015 | — |
| +2 | K093672 | Aegis Navigation Anda Egis Pelvic Application | Sentinelle Medical, Inc. | 2009 | — |
| +2 | K100793 | Urostation 3D Prostate Suite | Koelis | 2010 | — |
| +3 | K131448 | 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second… | Koelis | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 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 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K963697 | Advanced Diagnostic Viewer (Adv)Summary page 1…ystem Class H1, CFR 21 892.2050. 3. Predicate Device Information: Predicate Device #1: Bio-Vascular, Inc., Advanced Diagnostic Viewer (ADV), 510(k) #K963697 Predicate Device #2 : Voxar Limited, Plug n View, version 1.0, 510(k) #K992654 4. Device Description: The 3Dnet Suite is… | 1996 |
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…Predicate Device #1: Bio-Vascular, Inc., Advanced Diagnostic Viewer (ADV), 510(k) #K963697 Predicate Device #2 : Voxar Limited, Plug n View, version 1.0, 510(k) #K992654 4. Device Description: The 3Dnet Suite is a software device for evaluating scanned images of selected human organ. The… | 1999 |
What descends from it? (34)
See all 343 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 10 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K081093 (Eigen, LLC, 2008) has gone furthest, with 31 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.
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 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans. The 3Dnet Suite provides several levels of functionality to the user: - basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvglP, MIP, MinIP, measurements, annotations, reporting, distribution…
Read the full statement (137 words)
The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.
The 3Dnet Suite provides several levels of functionality to the user:
- basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvglP, MIP, MinIP, measurements, annotations, reporting, distribution etc.
- tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc.
- Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, measurement and visualization, including colon screening which is indented for the reviewing of patients for colonic polyps, tumors and other lesions using tomographic colonography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063107: 3DNET Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063107
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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