510(k) · Cleared
ClearedQplaque MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 4, 2008 as substantially equivalent to K050376 (Medical Technologies International, Inc., 2005) and 4 other predicates after a 117-day review. Its family tree reaches back 10 generations to 1991. 21 later devices descend from it.
- Decided
- Mar 4, 2008
- Review
- 117 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K913770 (1991). 43 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- This deviceK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- Descendant · cites it directly · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- Descendant · 3 generations on · 11 of its ownK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- Descendant · 3 generations on · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · 4 generations on · 8 of its ownK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- This deviceK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · cites it directly19descendants
- K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · 2 generations on12descendants
- K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018 · 3 generations on11descendants
- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · 3 generations on9descendants
- K192923Vitrea Software PackageCanon Medical Systems Corporation · 2020 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −1 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| 0 (this device) | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| +1 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +2 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| +3 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| +3 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +4 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K050376 | ProwinSummary page 1…QPlaque MR Device Class. Name Class II; PACS software Regulation Number 21 CFR 892.1000 (90 LNH) • Predicate Device(s) - Prowin K050376; - SonoCalc K030223; - Plaque View K0431 11; - Vitrtea K071331; - Viatronix V3D Vascular… | 2005 |
| * | K030223 | SonocalcSummary page 1…que MR Device Class. Name Class II; PACS software Regulation Number 21 CFR 892.1000 (90 LNH) • Predicate Device(s) - Prowin K050376; - SonoCalc K030223; - Plaque View K0431 11; - Vitrtea K071331; - Viatronix V3D Vascular… | 2003 |
| * | K043111 | Plaqueview Software, Model CSPV-0001ASummary page 1…e Regulation Number 21 CFR 892.1000 (90 LNH) • Predicate Device(s) - Prowin K050376; - SonoCalc K030223; - Plaque View K0431 11; - Vitrtea K071331; - Viatronix V3D Vascular K033361 * Device Description QPlaque MR is able to… | 2004 |
| * | K071331 | Vitrea Version 4.0Summary page 1…21 CFR 892.1000 (90 LNH) • Predicate Device(s) - Prowin K050376; - SonoCalc K030223; - Plaque View K0431 11; - Vitrtea K071331; - Viatronix V3D Vascular K033361 * Device Description QPlaque MR is able to read DICOM MR imag… | 2007 |
| * | K033361 | Viatronix V3D Vascular, Revision 1.0Summary page 1…Prowin K050376; - SonoCalc K030223; - Plaque View K0431 11; - Vitrtea K071331; - Viatronix V3D Vascular K033361 * Device Description QPlaque MR is able to read DICOM MR images from all major MR vendors. Vessel analysis data, generated by se… | 2003 |
What descends from it? (21)
See all 212 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)
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 5 companies; a new generation was cleared every 11 months on median.
- 9 of the 43 ancestors have a recall of any class.
- Of its descendants, K120636 (Fujifilm Medical System U.S.A., Inc., 2012) has gone furthest, with 19 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
QPlaque MR is a post-processing software application that is intended to assist trained cardiologists and radiologists in the assessment of atherosclerosis. The software is intended in particular to aid in assessing vessel wall thickness and remodeling in the carotid arteries I QPlaque MR post-processes multi-spectral MR images to semi-automatically determine the boundaries of the lumen and outer vessel wall, and provides editing tools for manual drawing…
Read the full statement (108 words)
QPlaque MR is a post-processing software application that is intended to assist trained cardiologists and radiologists in the assessment of atherosclerosis. The software is intended in particular to aid in assessing vessel wall thickness and remodeling in the carotid arteries I QPlaque MR post-processes multi-spectral MR images to semi-automatically determine the boundaries of the lumen and outer vessel wall, and provides editing tools for manual drawing of plaque components. The software enables area and volume measurements of the vessel wall as well as quantification of user-indicated areas. QPlaque MR results can be used to support the decision-making process in clinical practice and to support conclusions in clinical trials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073156 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073156: Qplaque MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073156
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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