510(k) · Cleared
ClearedViatronix V3D Vascular, Revision 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viatronix, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 5, 2003 as substantially equivalent to K993792 (Ge Medical Systems, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1993. 22 later devices descend from it.
- Decided
- Nov 5, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926258 (1993). 4 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK926258 DLXGE Medical Systems · 1993
- 1 generation backK993792 Smart Vessel Analysis (Smart VA) OptionGe Medical Systems, Inc. · 1999
- This deviceK033361 Viatronix V3D Vascular, Revision 1.0Viatronix, Inc. · 2003
- Descendant · cites it directly · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- Descendant · 2 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 3 generations on · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- Descendant · 4 generations on · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- Descendant · 4 generations on · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · cites it directly21descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 2 generations on19descendants
- K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · 3 generations on12descendants
- K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · 4 generations on11descendants
- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926258 | DLX | GE Medical Systems | 1993 | — |
| −1 | K993792 | Smart Vessel Analysis (Smart VA) Option | Ge Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K033361 | Viatronix V3D Vascular, Revision 1.0 | Viatronix, Inc. | 2003 | — |
| +1 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| +2 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +3 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| +4 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| +4 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 21.6 · 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 |
|---|---|---|---|
| * | K993792 | Smart Vessel Analysis (Smart VA) OptionSummary page 1…c) Classification name: 9OLLZ- Image Processing system 3. Predicate Device Information: Predicate Device #1: G.E. Medical -Smart Vessel Analysis Option,5 1O(k) ## K993792. Predicate Device #2: Vital Images Vitrea 2, Version 2.1, 5 10(k) # KO025 19. 4. Device Description: The V-3D Vasc… | 1999 |
| * | K002519 | Vitrea 2, Version 2.1 | 2000 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073156 | Qplaque MR | 2008 | 21 |
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 6.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K073156 (Medis Medical Imaging Systems BV, 2008) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K993792.
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 Viatronix V3D Vascular is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MFU scans or 3D X-Ray angiography of the selected human vessels, e.g., the coronary arteries, the carotid arteries, the peripheral arteries, the aorta, arteries of the brain, and any opacified veins. The goal of this device is to automate routine inspection of human vessels to detect stenosis, plaque, bulge, aneurismal sac and…
Read the full statement (136 words)
The Viatronix V3D Vascular is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MFU scans or 3D X-Ray angiography of the selected human vessels, e.g., the coronary arteries, the carotid arteries, the peripheral arteries, the aorta, arteries of the brain, and any opacified veins. The goal of this device is to automate routine inspection of human vessels to detect stenosis, plaque, bulge, aneurismal sac and dissection in the vessel. It also supports the interactive segmentation of any vessel by hiding certain parts of the data set from display for critical evaluation of selected part(s) of vessel. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, measure, evaluate, archive, print and distribute DICOM 3 .O compliant vessel image studies, utilizing PC hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033361 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033361: Viatronix V3D Vascular, Revision 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033361
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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