510(k) · Cleared
ClearedMR-CT Vva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LLZ System, Image Processing, Radiological
Cleared on Jan 6, 2015 as substantially equivalent to K073194 (Cardiovascular Imaging Solutions, Ltd., 2008) and 1 other predicate after a 305-day review. Its family tree reaches back 5 generations to 1994. 19 later devices descend from it.
- Decided
- Jan 6, 2015
- Review
- 305 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940172 (1994). 18 ancestors in all, the oldest K871859 (1987). 19 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 4 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 3 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 2 generations backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- 1 generation backK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- This deviceK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- Descendant · cites it directly · 5 of its ownK191125 ADAS 3DGalgo Medical S.L · 2020
- Descendant · cites it directly · 5 of its ownK162513 Arterys Software v2.0Arterys, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK210850 ADAS 3DAdas3D Medical S.L. · 2021
- Descendant · cites it directly · 4 of its ownK163253 Arterys Cardio DLArterys, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK212421 ADAS 3DAdas3D Medical S.L. · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K191125ADAS 3DGalgo Medical S.L · 2020 · cites it directly5descendants
- K162513Arterys Software v2.0Arterys, Inc. · 2016 · cites it directly5descendants
- K210850ADAS 3DAdas3D Medical S.L. · 2021 · 2 generations on4descendants
- K163253Arterys Cardio DLArterys, Inc. · 2017 · cites it directly4descendants
- K212421ADAS 3DAdas3D Medical S.L. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −4 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −3 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −2 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| −1 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| 0 (this device) | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| +1 | K191125 | ADAS 3D | Galgo Medical S.L | 2020 | — |
| +1 | K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016 | — |
| +2 | K210850 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
| +1 | K163253 | Arterys Cardio DL | Arterys, Inc. | 2017 | — |
| +3 | K212421 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsSummary page 4…ption : Picture Archiving and Communications System Regulation / Procode :21 CFR 892.2050/LLZ Predicate Devices e The Cardiovascular Imaging Solutions Ltd.: CMRtools™ (K073194) e The GE Healthcare: CardiacVX™ (K121762) Device Description MR-CT VVA (MR-CT Vessel and Ventricular Analysis) is image post-p… | 2008 |
| * | K121762 | Cardiac VXSummary page 4…ns System Regulation / Procode :21 CFR 892.2050/LLZ Predicate Devices e The Cardiovascular Imaging Solutions Ltd.: CMRtools™ (K073194) e The GE Healthcare: CardiacVX™ (K121762) Device Description MR-CT VVA (MR-CT Vessel and Ventricular Analysis) is image post-processing software for the viewing and qua… | 2013 |
| † | K994283 | Mri- Magnetic Resonance Analytical Software System | 2000 |
| † | K033774 | CT-Mass | 2004 |
| † | K994282 | Mri- Flow Analytical Software Package | 2000 |
| † | K993761 | Cardiovascular Measurement System - View | 1999 |
| † | K040746 | Mra-CMS | 2004 |
What descends from it? (19)
See all 198 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 21 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K191125 (Galgo Medical S.L, 2020) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K073194.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, MR-CT VVA allows the quantification of T2* in MR images of the heart and the liver. Finally, MR-CT VVA can be used for the quantification of cerebral spinal fluid in MR…
Read the full statement (148 words)
MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, MR-CT VVA allows the quantification of T2* in MR images of the heart and the liver. Finally, MR-CT VVA can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images.
When the quantified results provided by MR-CT VVA are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140587: MR-CT Vva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140587
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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