510(k) · Cleared
Recalled · Class II · 2013VITREA2, Version 3.7 Medical Image Processing System
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 Dec 15, 2004 as substantially equivalent to K040305 (Vital Images, Inc., 2004) and 3 other predicates after a 12-day review. Its family tree reaches back 6 generations to 1991. 143 later devices descend from it. It has been recalled once.
- Decided
- Dec 15, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K913770 (1991). 22 ancestors in all. 143 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 2 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 1 generation backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- This deviceK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004
- Descendant · cites it directly · 117 of its ownK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- Descendant · 5 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
Showing 5 of 143 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 143 · See all- K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · cites it directly117descendants
- K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 2 generations on111descendants
- K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 3 generations on82descendants
- K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · 4 generations on21descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −2 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −1 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| 0 (this device) | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | — |
| +1 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| +2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| +3 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| +4 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| +5 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
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 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2011 | 1 | 0 |
| 2012 | 9 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 15 | 0 |
| 2025 | 16 | 0 |
| 2026 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K040305 | VITREA2 Version 3.5Summary page 1…age Processing, Radiological Name Classification Name LLZ, Class II, CFR 21 892.2050 * Vitrea2, Version 3.5 (K040305) Nersion 3.4 (K032748) Vital Images, Inc.… | 2004 |
| * | K032748 | VITREA2, Version 3.4 Medical Image Processing SoftwareSummary page 1…LLZ, Class II, CFR 21 892.2050 * Vitrea2, Version 3.5 (K040305) Nersion 3.4 (K032748) Vital Images, Inc. * Toshiba Cardiac Functional… | 2003 |
| * | K023760 | CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001BSummary page 1…(K032748) Vital Images, Inc. * Toshiba Cardiac Functional Analysis (K(023760) Predicate Devices Toshiba America Medical Systems, Inc.… | 2002 |
| * | K023003 | Imagechecker-CT WorkstationSummary page 1…Predicate Devices Toshiba America Medical Systems, Inc. * F12 ImageChecker - LN500 (K023003) R2 Technologies, Inc. Device Description… | 2002 |
What descends from it? (143)
See all 1435 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2013 | Class II | Z-1144-2013 | Software design | Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table … |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K052632 (Vital Images, Inc., 2005) has gone furthest, with 117 descendants of its own.
- 2 other devices also cite its predicate K040305.
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?
Vitrea 2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, the Vitrea2 Version 3.7 has the following additional indications: CT Colonography The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging…
Read the full statement (366 words)
Vitrea 2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, the Vitrea2 Version 3.7 has the following additional indications:
CT Colonography The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.
CT Cardiac The separately-licensed CT Cardiac option contains two components: Coronary Artery Analysis and Cardiac Functional Analysis. The Vital Images' CT Cardiac option provides a variety of tools and views for working with clinical CT images of the coronary arteries, heart, and surrounding tissue.
Coronary Artery Analysis
The Coronary Artery Analysis component of the Vitrea CT Cardiac option is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive approach to survey a patient's coronary arteries. The vessel probe technology integrated into the CT Cardiac option allows physicians' to click on an artery to simultaneously view the following: the highlighted vessel in 3D, two curved vessel views orthogonal to each other, and cross-sectional views.
Cardiac Functional Analysis
The Cardiac Functional Analysis (CFA) component of the Vitrea CT Cardiac 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 CFA component of the CT Cardiac option includes semi-automatic heart and left ventricle 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.
Lung Analysis The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043333: VITREA2, Version 3.7 Medical Image Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043333
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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