510(k) · Cleared
ClearedAdvanced Diagnostic Viewer (Adv)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 27, 1996 as substantially equivalent to K953259 (Vital Images, Inc., 1995) after a 72-day review. Its family tree reaches back 1 generation to 1995. 35 later devices descend from it.
- Decided
- Nov 27, 1996
- Review
- 72 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953259 (1995). 35 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK953259 VoxelviewVital Images, Inc. · 1995
- This deviceK963697 Advanced Diagnostic Viewer (Adv)Bio-Vascular, Inc. · 1996
- Descendant · cites it directly · 34 of its ownK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- Descendant · 2 generations on · 31 of its ownK081093 3-D Imaging WorkstationEigen, LLC · 2008
- Descendant · 3 generations on · 11 of its ownK153073 UroNav (Version 2.0)Invivo Corporation · 2015
- Descendant · 3 generations on · 8 of its ownK093672 Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK100793 Urostation 3D Prostate SuiteKoelis · 2010
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K0631073DNET SuiteBiotronics3D, Ltd. · 2006 · cites it directly34descendants
- K0810933-D Imaging WorkstationEigen, LLC · 2008 · 2 generations on31descendants
- K153073UroNav (Version 2.0)Invivo Corporation · 2015 · 3 generations on11descendants
- K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009 · 3 generations on8descendants
- K100793Urostation 3D Prostate SuiteKoelis · 2010 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953259 | Voxelview | Vital Images, Inc. | 1995 | — |
| 0 (this device) | K963697 | Advanced Diagnostic Viewer (Adv) | Bio-Vascular, Inc. | 1996 | — |
| +1 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| +2 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| +3 | K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015 | — |
| +3 | K093672 | Aegis Navigation Anda Egis Pelvic Application | Sentinelle Medical, Inc. | 2009 | — |
| +3 | K100793 | Urostation 3D Prostate Suite | Koelis | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K953259 | VoxelviewSummary page 1…f 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 1. Predicate Device VoxelView® 2.5 (K953259). 2. Device Description ADV is software used for 3D image processing of CT and MR diagnostic images. 3. Intended Use ADV is int… | 1995 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063107 | 3DNET Suite | 2006 | 34 |
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?
- Its one ancestor has no recall.
- Of its descendants, K063107 (Biotronics3D, Ltd., 2006) has gone furthest, with 34 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?
ADV is intended to create 3D images of the anatomy from a set of CT or MRI images.
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/K963697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963697: Advanced Diagnostic Viewer (Adv).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963697
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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