510(k) · Cleared
ClearedCaas MRV Version 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical Imaging BV · LLZ System, Image Processing, Radiological
Cleared on Apr 19, 2006 as substantially equivalent to K994283 (Medis Medical Imaging Systems BV, 2000) after a 13-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Apr 19, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940172 (1994). 4 later devices descend from it, 2 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 deviceK060941 Caas MRV Version 3.0Pie Medical Imaging BV · 2006
- Descendant · cites it directly · 2 of its ownK162112 Caas MRVPie Medical Imaging BV · 2016
- Descendant · cites it directly · 2 of its ownK090155 Caas MR Flow 1.0Pie Medical Imaging BV · 2009
- Descendant · 2 generations on · 1 of its ownK181825 CAAS MR SolutionsPie Medical Imaging BV · 2018
- Descendant · 3 generations on · 0 of its ownK232007 CAAS MR SolutionsPie Medical Imaging BV · 2024
Most influential descendants
Showing 4 of 4 · See all- K162112Caas MRVPie Medical Imaging BV · 2016 · cites it directly2descendants
- K090155Caas MR Flow 1.0Pie Medical Imaging BV · 2009 · cites it directly2descendants
- K181825CAAS MR SolutionsPie Medical Imaging BV · 2018 · 2 generations on1descendant
- K232007CAAS MR SolutionsPie Medical Imaging BV · 2024 · 3 generations on0descendants
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) | K060941 | Caas MRV Version 3.0 | Pie Medical Imaging BV | 2006 | — |
| +1 | K162112 | Caas MRV | Pie Medical Imaging BV | 2016 | — |
| +1 | K090155 | Caas MR Flow 1.0 | Pie Medical Imaging BV | 2009 | — |
| +2 | K181825 | CAAS MR Solutions | Pie Medical Imaging BV | 2018 | — |
| +3 | K232007 | CAAS MR Solutions | Pie Medical Imaging BV | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 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? (1)
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 |
|---|---|---|---|
| * | K994283 | Mri- Magnetic Resonance Analytical Software SystemSummary page 1…y Class II. The CAAS MRV software package is substantially equivalent to the quantitative analysis software package MRI-Magnetic resonance Analytical Software System, K994283. The CAAS MRV is a software tool designed for the fimctional analysis of the heart based on multi-slice, multi-phase MR images o… | 2000 |
What descends from it? (4)
2 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 12 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, K162112 (Pie Medical Imaging BV, 2016) has gone furthest, with 2 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.
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?
1. Delineate the inner and outer wall of the ventricles automatically, semi-automatically or manually, as well as the papillary muscles, on different kinds of MRI images.
2. Derive from these images and contours quantitative information to be used to assist in cardiac analysis
The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060941: Caas MRV Version 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060941
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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