510(k) · Cleared
Recalled · Class II · 2013VITREA2, Version 3.4 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 Oct 29, 2003 as substantially equivalent to K002519 (Vital Images, Inc., 2000) and 3 other predicates after a 54-day review. Its family tree reaches back 4 generations to 1991. 170 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 29, 2003
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 4 generations to K913770 (1991). 10 ancestors in all. 170 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- This deviceK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003
- Descendant · cites it directly · 164 of its ownK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- Descendant · cites it directly · 143 of its ownK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 117 of its ownK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
Showing 5 of 170 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 170 · See all- K040305VITREA2 Version 3.5Vital Images, Inc. · 2004 · cites it directly164descendants
- K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · cites it directly143descendants
- K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · 2 generations on117descendants
- K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 3 generations on111descendants
- K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 4 generations on82descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| 0 (this device) | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | — |
| +1 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| +1 | 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 |
| +3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| +4 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 13 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 16 | 0 |
| 2025 | 19 | 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 |
|---|---|---|---|
| * | K002519 | Vitrea 2, Version 2.1Summary page 1…, Image Processing, Radiological Classification Name LLZ, Class II, CFR 21 892.2050 Vital Images, Inc., Vitrea2, Version 2.1 (K002519) GE, Advantage Workstation 4.1 (K020483) Predicate Devices R2 Te… | 2000 |
| * | K020483 | Advantage Workstation 4.1Summary page 1…ass II, CFR 21 892.2050 Vital Images, Inc., Vitrea2, Version 2.1 (K002519) GE, Advantage Workstation 4.1 (K020483) Predicate Devices R2 Technologies, Inc., ImageChecker-CT Workstation (K023003)… | 2002 |
| * | K023003 | Imagechecker-CT WorkstationSummary page 1…GE, Advantage Workstation 4.1 (K020483) Predicate Devices R2 Technologies, Inc., ImageChecker-CT Workstation (K023003) GE, Advanced Lung Analysis (K013381) Device Description VitreaTM2is a medical diagnostic works… | 2002 |
| * | K013381 | Advanced Lung Analysis-1Summary page 1…redicate Devices R2 Technologies, Inc., ImageChecker-CT Workstation (K023003) GE, Advanced Lung Analysis (K013381) Device Description VitreaTM2is a medical diagnostic workstation that allows the processing, review, analysis, communication an… | 2001 |
What descends from it? (170)
See all 1704 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-1181-2013 | Labeling design | Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This… |
| 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 12 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K040305 (Vital Images, Inc., 2004) has gone furthest, with 164 descendants of its own.
- 12 other devices also cite its predicate K002519.
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?
Vitream2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, VitreaTM2 has the following specific indications. VScorem (K990442) is an option within the VitreaT‘2 application and is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and…
Read the full statement (254 words)
Vitream2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, VitreaTM2 has the following specific indications.
VScorem (K990442) is an option within the VitreaT‘2 application and 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 (K001682) and Auto Gate (K003230), allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Automated Vascular Measurement (KO02519) is an option within the VitreaTM2 application and is intended for study/analysis of selected vessels for stenosis analysis, prelpost stent planning and directionalvessel tortuosity evaluation.
Tumor Volume Measurement (K002519) is an option within the VitreaTM2 application and is intended for the analysislquantification of tumor volumes obtained from MR brain series scans.
CT Brain Perfusion (K003639) is an option within the VitreaTM2 application and is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
ImageCheckerCT is an option within the VitreaTM2 application and is intended for the display of a composite view of 2 0 cross-sections, and 3D volumes of Chest CT images, including findings of regions of interest (“ROI”) identified by the radiologist, or Computer Assisted Detection (“CAD”) findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032748: VITREA2, Version 3.4 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/K032748
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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