510(k) · Cleared
Recalled · Class II · 2013VITREA2 Version 3.8 Medical Image Processing Software
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, 2005 as substantially equivalent to K043333 (Vital Images, Inc., 2004) after an 80-day review. Its family tree reaches back 7 generations to 1991. 117 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 15, 2005
- Review
- 80 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 23 ancestors in all. 117 later devices descend from it, 5 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 deviceK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005
- Descendant · cites it directly · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- Descendant · 4 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 2 generations on · 19 of its ownK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · cites it directly111descendants
- K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 2 generations on82descendants
- K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · 3 generations on21descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 4 generations on19descendants
- K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009 · 2 generations on19descendants
View 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) | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | — |
| +1 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| +2 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| +3 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| +4 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +2 | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
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 |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 8 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 14 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K043333 | VITREA2, Version 3.7 Medical Image Processing SystemSummary page 1…ssing, Radiological Name Classification Name LLZ, Class II, CFR 21 892.2050 Vitrea2, Version 3.7 (K043333) Predicate Devices Vital Images, Inc. Device Description… | 2004 |
What descends from it? (117)
See all 1175 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 … |
| Aug 13, 2012 | Class II | Z-0186-2013 | Software design | Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K061624 (Vital Images, Inc., 2006) has gone furthest, with 111 descendants 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.
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?
Vitrea2 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. Cardiac Functional Analysis (CFA) The CT 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 CFA option includes semi-automatic heart and left…
Read the full statement (437 words)
Vitrea2 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.
Cardiac Functional Analysis (CFA)
The CT 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 CFA 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.
Coronary Artery Analysis
The separately-licensed CT Cardiac option includes CT Coronary Artery Analysis, which is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive survey of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.
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.
Vessel Probe
The separately-licensed general Vessel Probe option is intended for determining the presence and extent of peripheral vascular obstructive disease by providing a non-invasive survey of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard Vitrea software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on a ratio of the smallest to the largest diameter. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Houndsfield unit or signal intensity statistics.
VScore
The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052632: VITREA2 Version 3.8 Medical Image Processing Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052632
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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