510(k) · Cleared
ClearedCaas MRV
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 Jul 27, 2004 as substantially equivalent to K994283 (Medis Medical Imaging Systems BV, 2000) after a 36-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jul 27, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940172 (1994). 1 later device descends from it, 1 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 deviceK041682 Caas MRVPie Medical Imaging BV · 2004
- Descendant · cites it directly · 0 of its ownK082510 Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D…Tomtec Imaging Systems GmbH · 2008
Most influential descendants
Showing 1 of 1 · See all- K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH · 2008 · cites it directly0descendants
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) | K041682 | Caas MRV | Pie Medical Imaging BV | 2004 | — |
| +1 | K082510 | Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis… | Tomtec Imaging Systems GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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…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 functional analysis of the heart based on multi-slice, multi-phase MR imag… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082510 | Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D… | 2008 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K082510 (Tomtec Imaging Systems GmbH, 2008) has gone furthest, with 0 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?
The CAAS MRV has been designed for quantitative functional analysis of the left and right ventricle of the heart based on multi-slice, multi-phase cine MRI images. Specifically, it enables the user to:
1. Delineate automatically or semi-automatically the inner and outer wall of the ventricles, as well as the papillary muscles, on the MRI images
2. Derive from these contours the global and regional functional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc.
The CAAS MRV has been designed to be used in everyday clinical practice, as well as for research purposes like clinical research trials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041682: Caas MRV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041682
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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