510(k) · Cleared
ClearedCmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Imaging Solutions, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Feb 14, 2008 as substantially equivalent to K994283 (Medis Medical Imaging Systems BV, 2000) after a 93-day review. Its family tree reaches back 3 generations to 1994. 28 later devices descend from it.
- Decided
- Feb 14, 2008
- Review
- 93 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940172 (1994). 28 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 2 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 1 generation backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- This deviceK073194 Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsCardiovascular Imaging Solutions, Ltd. · 2008
- Descendant · cites it directly · 19 of its ownK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- Descendant · cites it directly · 6 of its ownK113620 Myrian 1.11Intrasense · 2012
- Descendant · 2 generations on · 5 of its ownK191125 ADAS 3DGalgo Medical S.L · 2020
- Descendant · 2 generations on · 5 of its ownK162513 Arterys Software v2.0Arterys, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK210850 ADAS 3DAdas3D Medical S.L. · 2021
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K140587MR-CT VvaMedis Medical Imaging Systems BV · 2015 · cites it directly19descendants
- K113620Myrian 1.11Intrasense · 2012 · cites it directly6descendants
- K191125ADAS 3DGalgo Medical S.L · 2020 · 2 generations on5descendants
- K162513Arterys Software v2.0Arterys, Inc. · 2016 · 2 generations on5descendants
- K210850ADAS 3DAdas3D Medical S.L. · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −2 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −1 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| 0 (this device) | K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools | Cardiovascular Imaging Solutions, Ltd. | 2008 | — |
| +1 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| +1 | K113620 | Myrian 1.11 | Intrasense | 2012 | — |
| +2 | K191125 | ADAS 3D | Galgo Medical S.L | 2020 | — |
| +2 | K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016 | — |
| +3 | K210850 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K060941 | FDA’s K060941 is Caas MRV Version 3.0 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K994283 | Mri- Magnetic Resonance Analytical Software SystemSummary page 1…on Names: System, image processing, radiological 892.2050 90-LLZ Substantially Equivalent to both: 510(k) Number K06941K994283 ame [DevceCassficaion system, image processing, system, nuclear magnet… | 2000 |
What descends from it? (28)
See all 284 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 14 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140587 (Medis Medical Imaging Systems BV, 2015) has gone furthest, with 19 descendants of its own.
- 7 other devices also cite its predicate K994283.
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?
CMRtoolsTM and plug-ins VentricularTools TM & ThalassaemiaToolsTM is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains…
Read the full statement (191 words)
CMRtoolsTM and plug-ins VentricularTools TM & ThalassaemiaToolsTM is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing cine images and performing region-of-interest analysis. Plug-ins are used for specialist cardiac assessment including VentricularTools for left ventricular assessment and ThalassaemiaTools for T2* image quantification. It is important that CMRtools is only used to view and analyze human cardiac and or liver images acquired with a cardiovascular magnetic resonance scanner. CMRtools must not be used to view or analyze images acquired with any other type of imaging device. The software must not be used to view or analyze images of any part of the body except the heart and or liver or the vascular system. Furthermore, the software must not be used to view or analyze images acquired from animals. Only DICOM images will be used for presentation, display and diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073194 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073194
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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