510(k) · Cleared
ClearedCardiac Function Analysis, Calcium Scoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziosoft, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 31, 2009 as substantially equivalent to K023760 (Toshiba America Medical Systems, In.C, 2002) and 2 other predicates after a 130-day review. Its family tree reaches back 5 generations to 1995. 29 later devices descend from it.
- Decided
- Mar 31, 2009
- Review
- 130 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945512 (1995). 14 ancestors in all, the oldest K945428 (1995). 29 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 4 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 3 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 2 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 1 generation backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- This deviceK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- Descendant · cites it directly · 25 of its ownK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- Descendant · 2 generations on · 17 of its ownK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- Descendant · 2 generations on · 7 of its ownK213998 cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022
- Descendant · 3 generations on · 4 of its ownK221100 Viz RV/LVViz. Ai, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011 · cites it directly25descendants
- K203256Imbio RV/LV SoftwareImbio, LLC · 2021 · 2 generations on17descendants
- K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022 · 2 generations on7descendants
- K221100Viz RV/LVViz. Ai, Inc. · 2022 · 3 generations on4descendants
- K230534BriefCase-QuantificationAidoc Medical, Ltd. · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −4 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −3 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −2 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −1 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| 0 (this device) | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| +1 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| +2 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| +2 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022 | — |
| +3 | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | — |
| +4 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K023760 | CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001BSummary page 1…Cardiac Function Analysis CT Cardiac Function Analysis Toshiba SoftwareK023760 Calcium Scoring Toshiba CSCS-001 A Calcium Scoring K072737… | 2002 |
| * | K072737 | CSCS-001A Calcium Scoring PackageSummary page 1…Toshiba SoftwareK023760 Calcium Scoring Toshiba CSCS-001 A Calcium Scoring K072737 Voxar Calcium Scoring K020140 510(k) Submission… | 2007 |
| * | K020140 | Voxar's Calcium Scoring ProductSummary page 1…Toshiba CSCS-001 A Calcium Scoring K072737 Voxar Calcium Scoring K020140 510(k) Submission Cardiac Function Analysis & Calcium Page 8 Ziosoft,… | 2002 |
What descends from it? (29)
See all 292 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?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K111373 (Circle Cardiovascular Imaging, Inc., 2011) has gone furthest, with 25 descendants of its own.
- 2 other devices also cite its predicate K023760.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Cardiac Function Analysis The Cardiac Function Analysis software option for use with Ziostation is intended for non-invasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display.…
Read the full statement (116 words)
Cardiac Function Analysis
The Cardiac Function Analysis software option for use with Ziostation is intended for non-invasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.
Calcium Scoring
The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083446: Cardiac Function Analysis, Calcium Scoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083446
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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