510(k) · Cleared
Recalled · 2011Vitrea, Version 3.9
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 Jun 27, 2006 as substantially equivalent to K052632 (Vital Images, Inc., 2005) and 1 other predicate after a 15-day review. Its family tree reaches back 8 generations to 1991. 111 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 29 ancestors in all. 111 later devices descend from it, 9 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 4 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 3 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 2 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 1 generation backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- This deviceK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006
- Descendant · cites it directly · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- Descendant · 3 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 19 of its ownK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
- Descendant · 2 generations on · 17 of its ownK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · See all- K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · cites it directly82descendants
- K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · 2 generations on21descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 3 generations on19descendants
- K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009 · cites it directly19descendants
- K072821Vitrea 4DCTVital Images, Inc. · 2008 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −4 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −3 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −2 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −1 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| 0 (this device) | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | — |
| +1 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| +2 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| +3 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
| +2 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
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 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 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? (2)
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 |
|---|---|---|---|
| * | K052632 | VITREA2 Version 3.8 Medical Image Processing SoftwareSummary page 1…ge Processing, Radiological Name Classification Name LLZ, Class II, CFR 21 892.2050 · Vitrea2, Version 3.8 (K052632) Vital Images, Inc. Predicate Devices · SUREPlaque TM (K04311… | 2005 |
| * | K043111 | Plaqueview Software, Model CSPV-0001ASummary page 1…· Vitrea2, Version 3.8 (K052632) Vital Images, Inc. Predicate Devices · SUREPlaque TM (K043111) Toshiba America Medical Systems, Inc. Device Description The Vitrea2 system is… | 2004 |
What descends from it? (111)
See all 1119 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071331 | Vitrea Version 4.0 | 2007 | 82 |
| K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | 2009 | 19 |
| K071362 | Vital Connect 4.1 | 2007 | 11 |
| K071000 | Myrian | 2007 | 8 |
| K091001 | Myrian 1.4 | 2009 | 7 |
| K113620 | Myrian 1.11 | 2012 | 6 |
| K063548 | Cor Analyzer 1, Version 1.4 | 2007 | 6 |
| K072242 | Cor Analyzer II, Model V1.7 | 2007 | 5 |
| K062328 | Vitreaaccess, Version 1.0 | 2006 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 6 of the 29 ancestors have a recall of any class.
- Of its descendants, K071331 (Vital Images, Inc., 2007) has gone furthest, with 82 descendants of its own.
- 4 other devices also cite its predicate K052632.
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. In addition, Vitrea2 Version 3.9 has the following additional indication:
The SUREPlaque TM tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061624 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061624: Vitrea, Version 3.9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061624
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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