510(k) · Cleared
ClearedCT42 Cardiac Computed Tomography (CT) Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circle Cardiovascular Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 23, 2011 as substantially equivalent to K083446 (Ziosoft, Inc., 2009) after a 99-day review. Its family tree reaches back 6 generations to 1995. 25 later devices descend from it.
- Decided
- Aug 23, 2011
- Review
- 99 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945512 (1995). 15 ancestors in all, the oldest K945428 (1995). 25 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 5 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 4 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 3 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 2 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 1 generation backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- This deviceK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- Descendant · cites it directly · 17 of its ownK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- Descendant · cites it directly · 7 of its ownK213998 cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK221100 Viz RV/LVViz. Ai, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK212624 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K203256Imbio RV/LV SoftwareImbio, LLC · 2021 · cites it directly17descendants
- K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022 · cites it directly7descendants
- K221100Viz RV/LVViz. Ai, Inc. · 2022 · 2 generations on4descendants
- K230534BriefCase-QuantificationAidoc Medical, Ltd. · 2023 · 3 generations on3descendants
- K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −5 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −4 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −3 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −2 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −1 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| 0 (this device) | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| +1 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| +1 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022 | — |
| +2 | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | — |
| +3 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | — |
| +2 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K083446 | Cardiac Function Analysis, Calcium ScoringSummary page 4…Tr aditional 510(k) DEVICE INDICATIONS FOR USE K083446 The Cardiac Function Analysis software option for use with Ziostation is intended Cardiac Function for… | 2009 |
What descends from it? (25)
See all 253 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 16 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K203256 (Imbio, LLC, 2021) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K083446.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
ct42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables; * Importing Cardiac CT Images in DICOM format * Supporting clinical diagnostics by qualitative analysis of the cardiac CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and…
Read the full statement (260 words)
ct42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.
It enables;
* Importing Cardiac CT Images in DICOM format
* Supporting clinical diagnostics by qualitative analysis of the cardiac CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multi-planner reconstructions of the images.
* Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images, specifically distance, area, volume and mass
* Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac CT images.
* Supporting clinical diagnostics by quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the ct42 is not restricted, however the image acquisition by a cardiac CT scanner may limit the use of the device for certain sectors of the general public.
ct42 shall not be used to view or analyze images of any part of the body except the cardiac CT images acquired from a cardiovascular CT scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111373: CT42 Cardiac Computed Tomography (CT) Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111373
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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