510(k) · Cleared
ClearedCAAS MR Solutions
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 Feb 1, 2024 as substantially equivalent to K181825 (Pie Medical Imaging BV, 2018) and 1 other predicate after a 210-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Feb 1, 2024
- Review
- 210 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K940172 (1994). 38 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 7 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 6 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 5 generations backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- 4 generations backK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- 3 generations backK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- 2 generations backK162112 Caas MRVPie Medical Imaging BV · 2016
- 1 generation backK181825 CAAS MR SolutionsPie Medical Imaging BV · 2018
- This deviceK232007 CAAS MR SolutionsPie Medical Imaging BV · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −7 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −6 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −5 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| −4 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| −3 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| −2 | K162112 | Caas MRV | Pie Medical Imaging BV | 2016 | — |
| −1 | K181825 | CAAS MR Solutions | Pie Medical Imaging BV | 2018 | — |
| 0 (this device) | K232007 | CAAS MR Solutions | Pie Medical Imaging BV | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K181825 | CAAS MR SolutionsSummary page 4…21 CFR 892.2050 Classification Product Code: LLZ Predicate Devices Primary predicate device: CAAS MR Solutions (K181825, 21 CFR 892.2050, LLZ) Secondary predicate device: Segment CMR (K163076, 21 CFR 892.2050, LLZ)… | 2018 |
| * | K163076 | Segment CMRSummary page 4…vices Primary predicate device: CAAS MR Solutions (K181825, 21 CFR 892.2050, LLZ) Secondary predicate device: Segment CMR (K163076, 21 CFR 892.2050, LLZ) II - Device Description CAAS MR Solutions is an image post-processing software package which offers funct… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 9 of the 38 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostics in the field of cardiology or radiology by means of segmentation of cardiovascular structures and enabling the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images as well as measurement and reporting tools by providing the following functionality: • Segmentation of…
Read the full statement (137 words)
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostics in the field of cardiology or radiology by means of segmentation of cardiovascular structures and enabling the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images as well as measurement and reporting tools by providing the following functionality:
• Segmentation of cardiovascular structures and calculation of quantitative results
• Support signal intensity analysis for the myocardium
• Quantification of MR parametric maps (such as T1, T2, T2* relaxation)
• Visualization and quantification of blood flow velocity and directions
When the results provided by CAAS MR Solutions are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232007: CAAS MR Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232007
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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