510(k) · Cleared
Recalled · Class II · 2013Vitreaadvanced
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 Nov 2, 2012 as substantially equivalent to K071331 (Vital Images, Inc., 2007) and 5 other predicates after a 196-day review. Its family tree reaches back 11 generations to 1991. 8 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2012
- Review
- 196 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 11 generations to K913770 (1991). 99 ancestors in all, the oldest K871859 (1987). 8 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- This deviceK121213 VitreaadvancedVital Images, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 3 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- Descendant · 4 generations on · 1 of its ownK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
- Descendant · 5 generations on · 0 of its ownK260973 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 1 generation backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- This deviceK121213 VitreaadvancedVital Images, Inc. · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · cites it directly5descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 2 generations on4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 3 generations on3descendants
- K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025 · 4 generations on1descendant
- K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | 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 |
| −2 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −1 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| 0 (this device) | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | — |
| +1 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +2 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +3 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
| +4 | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | — |
| +5 | K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 12 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K071331 | Vitrea Version 4.0Summary page 1…Manufacturer TradeName - 51O0(k) Number Advanced Image Post- Vital Images, Inc., Vitreae, Version 4.0 K071331 processing Vitrea® CT Body Perfusion Medical America Toshiba… | 2007 |
| * | K090504 | CSBP-001A Body Perfusion SystemSummary page 1…rocessing Vitrea® CT Body Perfusion Medical America Toshiba CSBP-001A Body K090504 System, Inc., Perfusion System MeVis - Center for… | 2009 |
| * | K051528 | Mevis Liveranalyser/Liverviewer SoftwareSummary page 1…System, Inc., Perfusion System MeVis - Center for Medical Diagnostic MeVis LiverAnalyser' K051 528 Vitrea®CT Liver Analysis Systems anld LiverViewer Software MEDIAN Technologies… | 2005 |
| * | K071241 | LMS-LiverSummary page 1…1 528 Vitrea®CT Liver Analysis Systems anld LiverViewer Software MEDIAN Technologies LMS-Liver K071241 Vital Images, Inc Vitres®4DCT K072821 Vitrea®CT Brain Perfusion Siem… | 2007 |
| * | K072821 | Vitrea 4DCTSummary page 1…MEDIAN Technologies LMS-Liver K071241 Vital Images, Inc Vitres®4DCT K072821 Vitrea®CT Brain Perfusion Siemens Medical syngo® Volume Perfusion- K038 Soluti… | 2008 |
| * | K073238 | Syngo Volume Perfusion-CT NeuroSummary page 5…I (Submission '(K(072821) CT Neuro Difrne Subject) (K073238) syngo® Volume… | 2008 |
What descends from it? (8)
3 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 28 of the 99 ancestors have a recall of any class.
- Of its descendants, K142521 (Fujifilm Meidcal Systems U.S.A.,Inc., 2014) has gone furthest, with 5 descendants of its own.
- 14 other devices also cite its predicate K071331.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Vitreadvanced is a medical diagnostic system for the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitreadvanced is not meant for primary image interpretation in mammography. It can be used with a variety of cleared Vitrea® based software applications. In addition, Vitreadvanced includes three Vitrea® applications: Vitrea® CT Body Perfusion is a…
Read the full statement (421 words)
Vitreadvanced is a medical diagnostic system for the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitreadvanced is not meant for primary image interpretation in mammography. It can be used with a variety of cleared Vitrea® based software applications. In addition, Vitreadvanced includes three Vitrea® applications:
Vitrea® CT Body Perfusion is a noninvasive post-processing application designed to evaluate perfusion of organs and tumors. The software can calculate perfusion characteristics from dynamic CT image data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and venous components of perfusion in organs. It supports evaluation of regions of interest and the visual inspection of time density curves. When used by a trained and qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.
Vitrea® CT Liver Analysis is a noninvasive post-processing application designed to evaluate liver tumors and plan for liver surgery. It displays images for analysis and preoperative liver surgery planning, such as organ segmentation, tumor segmentation and intrahepatic vessels segmentation, as well as the approximation of vascular territories. It supports preoperative evaluation of specific surgery strategies by allowing the user to interactively define virtual resections splitting the liver. It also allows the user to evaluate safety-margins around lesions and to identify affected vascular branches and territories. Vitrea® CT Liver Analysis also provides automatic registration of multiple series and measurement tools for characterization and follow-up of the lesions. When used by a trained and qualified physician a potential application is to assist in the assessment of tumor response to therapy.
Vitrea® CT Brain Perfusion is a noninvasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time density curves. Vitrea® CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121213: Vitreaadvanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121213
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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