510(k) · Cleared
ClearedVoxar 3D Product Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voxar Limited · LLZ System, Image Processing, Radiological
Cleared on Jan 11, 2005 after a 54-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jan 11, 2005
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK043194 Voxar 3D Product FamilyVoxar Limited · 2005
- Descendant · cites it directly · 6 of its ownK132853 NovapacsNovarad Corp. · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK160371 NovaPACSNovarad Corporation · 2016
- Descendant · 3 generations on · 4 of its ownK171754 NovaPACSNovarad Corporation · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK231662 Aid-UIaid · 2024
- Descendant · 4 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K132853NovapacsNovarad Corp. · 2014 · cites it directly6descendants
- K160371NovaPACSNovarad Corporation · 2016 · 2 generations on5descendants
- K171754NovaPACSNovarad Corporation · 2017 · 3 generations on4descendants
- K231662Aid-UIaid · 2024 · 4 generations on1descendant
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043194 | Voxar 3D Product Family | Voxar Limited | 2005 | — |
| +1 | K132853 | Novapacs | Novarad Corp. | 2014 | 2 |
| +2 | K160371 | NovaPACS | Novarad Corporation | 2016 | — |
| +3 | K171754 | NovaPACS | Novarad Corporation | 2017 | 1 |
| +4 | K231662 | Aid-U | Iaid | 2024 | — |
| +4 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132853 | Novapacs | 2014 | 6 |
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?
- Of its descendants, K132853 (Novarad Corp., 2014) has gone furthest, with 6 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 Voxar 3D product family is a suite of products thct is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpretin9 DICOM comp!iant tomogiaphic medical imaging. The Voxar 3D product family provides several levels of functionality to the user:- * Basic analysis tools they use on a daily basis, such as 2D review, orthogonal multi planar reconstructions (mpr's), oblique mpr's, curved / cross - curved…
Read the full statement (203 words)
The Voxar 3D product family is a suite of products thct is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpretin9 DICOM comp!iant tomogiaphic medical imaging.
The Voxar 3D product family provides several levels of functionality to the user:-
* Basic analysis tools they use on a daily basis, such as 2D review, orthogonal multi planar reconstructions (mpr's), oblique mpr's, curved / cross - curved MPR's, slab MPR's AvelP, MIP, MiniP, measurements, annotations, reporting, distribution, etc
* Tools for in depth analysis, such as segmentation, enescopic review, colour VR slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc
* Specialist tools and workflow enhancements for specific clinical applications which provide targeted workflows, custom UI, targeted measurement and reporting functions including colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), calcium scoring (which is intended for non - invasive identification and quantification of calcifieatherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel analysis (which is intended for the qualative and quantative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043194: Voxar 3D Product Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043194
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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