510(k) · Cleared
ClearedVoxar's Calcium Scoring Product
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 28, 2002 after a 12-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 31 later devices descend from it.
- Decided
- Jan 28, 2002
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK020140 Voxar's Calcium Scoring ProductVoxar Limited · 2002
- Descendant · cites it directly · 29 of its ownK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- Descendant · 2 generations on · 25 of its ownK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- Descendant · 3 generations on · 17 of its ownK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- Descendant · 3 generations on · 7 of its ownK213998 cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022
- Descendant · 4 generations on · 4 of its ownK221100 Viz RV/LVViz. Ai, Inc. · 2022
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009 · cites it directly29descendants
- K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011 · 2 generations on25descendants
- K203256Imbio RV/LV SoftwareImbio, LLC · 2021 · 3 generations on17descendants
- K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022 · 3 generations on7descendants
- K221100Viz RV/LVViz. Ai, Inc. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020140 | Voxar's Calcium Scoring Product | Voxar Limited | 2002 | — |
| +1 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| +2 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| +3 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| +3 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022 | — |
| +4 | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 1 | 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? (31)
See all 312 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, K083446 (Ziosoft, Inc., 2009) has gone furthest, with 29 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?
Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using CT image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020140: Voxar's Calcium Scoring Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020140
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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