510(k) · Cleared
ClearedVitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 1, 2014 as substantially equivalent to K043333 (Vital Images, Inc., 2004) and 1 other predicate after a 74-day review. Its family tree reaches back 7 generations to 1991. 2 later devices descend from it.
- Decided
- Aug 1, 2014
- Review
- 74 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913770 (1991). 27 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 3 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 2 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 1 generation backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- This deviceK141302 Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK241038 Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging · 2024
- Descendant · 2 generations on · 0 of its ownK242781 cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −3 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −2 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −1 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| 0 (this device) | K141302 | Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa) | Vital Images, Inc. | 2014 | — |
| +1 | K241038 | Cardiac CT Function Software Application | Circle Cardiovascular Imaging | 2024 | — |
| +2 | K242781 | cvi42 Software Application | Circle Cardiovascular Imaging, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K043333 | VITREA2, Version 3.7 Medical Image Processing SystemSummary page 4…(k) number Vitrea 2, version 3.7 Medical Image Processing Software – Cardiac Vital Images, Inc. K043333 Functional Analysis (Legally Marketed Device) CardIQ Function Xpress… | 2004 |
| * | K073153 | Cardiq Function XpressSummary page 4…Functional Analysis (Legally Marketed Device) CardIQ Function Xpress GE Medical Systems SCS K073153 (Legally Marketed Device) Vitrea® CT Multi-Chamber Cardiac Function… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241038 | Cardiac CT Function Software Application | 2024 | 1 |
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 23 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 5 of the 27 ancestors have a recall of any class.
- Of its descendants, K241038 (Circle Cardiovascular Imaging, 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K043333.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation…
Read the full statement (104 words)
The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141302: Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141302
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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