510(k) · Cleared
ClearedMri-Plaque View, Version 1.1.2003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vpdiagnostics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 5, 2008 as substantially equivalent to K071331 (Vital Images, Inc., 2007) and 1 other predicate after an 88-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Dec 5, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 44 ancestors in all. No later device cites it as a predicate yet.
- 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 backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- This deviceK082607 Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc. · 2008
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 backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- This deviceK082607 Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc. · 2008
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 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| 0 (this device) | K082607 | Mri-Plaque View, Version 1.1.2003 | Vpdiagnostics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K071331 | Vitrea Version 4.0Summary page 1…substantially equivalent to the following devices: Model: Vitrea Version 4.0 with SUREPlaque Manufacturer: Vital Images 51OK Number: K071331 Model: QPlaque-MR Manufacturer: Medis 510K Number: K073156 4. Device Descriptio… | 2007 |
| * | K073156 | Qplaque MRSummary page 1…4.0 with SUREPlaque Manufacturer: Vital Images 51OK Number: K071331 Model: QPlaque-MR Manufacturer: Medis 510K Number: K073156 4. Device Description: MRI-PlaqueView is an image analysis software toolbox that facilitates visualization and q… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 9 of the 44 ancestors have a recall of any class.
- 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. 2008, 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?
The MRI-PlaqueView software provides a set of post-processing tools to assist trained cardiologists and radiologists in the quantitative analysis of atherosclerotic carotid arteries from 1.5T or 3.OT magnetic resonance imaging (MRI) studies acquired with a combination of one or more contrast weightings such as TI, T2, Proton Density, and Time of Flight. Users of MRI-PlaqueView perform semi- automatic delineation of lumen and outer vessel wall boundaries.…
Read the full statement (172 words)
The MRI-PlaqueView software provides a set of post-processing tools to assist
trained cardiologists and radiologists in the quantitative analysis of atherosclerotic
carotid arteries from 1.5T or 3.OT magnetic resonance imaging (MRI) studies
acquired with a combination of one or more contrast weightings such as TI, T2,
Proton Density, and Time of Flight. Users of MRI-PlaqueView perform semi-
automatic delineation of lumen and outer vessel wall boundaries. Users may also
perform semi-automatic, user configurable segmentation or manual drawing for
delineation of atherosclerotic plaque components within the vessel wall. Users may
edit the results on the fly. The software enables length, thickness, area, and volume
measurements of the vessel wall as well as quantification of user-indicated areas.
MRI-PlaqueView further aids in the visualization of atherosclerotic arteries (for
example, through maximum intensity projections) of MRI data and color-coded maps
of segmented arteries. When interpreted by a trained physician, the output of this
image analysis toolbox can be used to support the decision-making process in clinical
practice or to support investigations in clinical research and trials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082607: Mri-Plaque View, Version 1.1.2003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082607
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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