510(k) · Cleared
Recalled · 2011Vitrea Version 4.0
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 May 25, 2007 as substantially equivalent to K061624 (Vital Images, Inc., 2006) and 3 other predicates after a 14-day review. Its family tree reaches back 9 generations to 1991. 82 later devices descend from it. It has been recalled once.
- Decided
- May 25, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 9 generations to K913770 (1991). 34 ancestors in all. 82 later devices descend from it, 15 citing it directly.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- This deviceK071331 Vitrea Version 4.0Vital Images, Inc. · 2007
- Descendant · cites it directly · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- Descendant · 2 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 17 of its ownK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- Descendant · cites it directly · 16 of its ownK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- Descendant · cites it directly · 15 of its ownK150258 Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 5 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 4 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- This deviceK071331 Vitrea Version 4.0Vital Images, Inc. · 2007
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · cites it directly21descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 2 generations on19descendants
- K072821Vitrea 4DCTVital Images, Inc. · 2008 · cites it directly17descendants
- K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012 · cites it directly16descendants
- K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc. · 2015 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −5 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −4 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −3 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −2 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −1 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| 0 (this device) | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | — |
| +1 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| +2 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| +1 | K122429 | Vessel Analysis and Autoplaque for Ors Visual | Object Research Systems (Ors), Inc. | 2012 | — |
| +1 | K150258 | Vitrea, Version 7.0 Medical Image Processing Software | Vital Images, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 2 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K061624 | Vitrea, Version 3.9Summary page 1…tem, Image Processing, Radiological Name Classification Name LLZ, Class II,CFR 21 892.2050 * Vitrea®, Version 3.9 (K061624) Vital Images, Inc. * EnSite Verismo TM (K05184… | 2006 |
| * | K051840 | Ensite Verismo SoftwareSummary page 1…* Vitrea®, Version 3.9 (K061624) Vital Images, Inc. * EnSite Verismo TM (K051840) St. Jude, Inc. Predicate Devices * CARD… | 2005 |
| * | K031261 | Card EPSummary page 1…* EnSite Verismo TM (K051840) St. Jude, Inc. Predicate Devices * CARD EP (K031 261) GE Medical Systems * SUREPIaque TM (K04311… | 2003 |
| * | K043111 | Plaqueview Software, Model CSPV-0001ASummary page 1…* CARD EP (K031 261) GE Medical Systems * SUREPIaque TM (K043111) Toshiba America Medical Systems, Inc. Device Description The Vitrea system is a me… | 2004 |
What descends from it? (82)
See all 8215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073156 | Qplaque MR | 2008 | 21 |
| K072821 | Vitrea 4DCT | 2008 | 17 |
| K122429 | Vessel Analysis and Autoplaque for Ors Visual | 2012 | 16 |
| K150258 | Vitrea, Version 7.0 Medical Image Processing Software | 2015 | 15 |
| K121213 | Vitreaadvanced | 2012 | 8 |
| K120484 | Visia Oncology | 2012 | 8 |
| K163071 | vascuCAP | 2017 | 3 |
| K131424 | Miplatform Medical Imaging Suite | 2013 | 1 |
| K091498 | Vitrea Endovascular Stent Planning Software | 2009 | 1 |
| K082693 | Resolutionmd, Release 2.1 | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2011 | Not classified | Z-0388-2012 | Software design | Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 7 of the 34 ancestors have a recall of any class.
- Of its descendants, K073156 (Medis Medical Imaging Systems BV, 2008) has gone furthest, with 21 descendants of its own.
- 8 other devices also cite its predicate K061624.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Vitrea 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. Vitrea is not meant for primary Image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indication: Cardiac EP Planning is a post processing advanced visualization application that is intended to be used for the…
Read the full statement (274 words)
Vitrea 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. Vitrea is not meant for primary Image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indication:
Cardiac EP Planning is a post processing advanced visualization application that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite®System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.
The SUREPlaque Tm software application is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. This software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels.
The Vessel Probe option is intended for viewing the anatomy and pathology 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 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 or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071331 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071331: Vitrea Version 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071331
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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