510(k) · Cleared
ClearedVoxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barcoview Mis Edinburgh · LLZ System, Image Processing, Radiological
Cleared on May 22, 2007 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.
- Decided
- May 22, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 8 citing it directly.
- This deviceK070831 Voxar 3D Enterprise with Colonmetrix and Pet/CT PerfusionBarcoview Mis Edinburgh · 2007
- Descendant · cites it directly · 14 of its ownK101662 Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010
- Descendant · 2 generations on · 13 of its ownK120361 Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012
- Descendant · 3 generations on · 5 of its ownK203103 Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021
- Descendant · 4 generations on · 4 of its ownK221677 Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022
- Descendant · 3 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc. · 2010 · cites it directly14descendants
- K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc. · 2012 · 2 generations on13descendants
- K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · 2021 · 3 generations on5descendants
- K221677Synapse 3D Base Tools v6.6Fujifilm Corporation · 2022 · 4 generations on4descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070831 | Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion | Barcoview Mis Edinburgh | 2007 | — |
| +1 | K101662 | Synapse 3D Basic Tools | Fujifilm Medical System U.S.A., Inc. | 2010 | — |
| +2 | K120361 | Synapse 3D Base Tools | Fujifilm Medical Systems U.S.A, Inc. | 2012 | — |
| +3 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | 2021 | — |
| +4 | K221677 | Synapse 3D Base Tools v6.6 | Fujifilm Corporation | 2022 | — |
| +3 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (25)
See all 258 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?
- Of its descendants, K101662 (Fujifilm Medical System U.S.A., Inc., 2010) has gone furthest, with 14 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. 2007, 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?
The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data. The Voxar 3D product family provides several levels of functionality: * Basic analysis tools used on a daily basis…
Read the full statement (300 words)
The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.
The Voxar 3D product family provides several levels of functionality:
* Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution.
* Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data, endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vascular and other tubular structures and boundary detection.
* Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows, custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Specialized clinical applications include:
o Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography),
o Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts)
o Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary arteries to evaluate occlusive and aneurismal disease),
o Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart),
o PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT scanners)
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K070831 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070831: Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070831
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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