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 Sep 21, 2016 as substantially equivalent to K060941 (Pie Medical Imaging BV, 2006) and 1 other predicate after a 54-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it.
- Decided
- Sep 21, 2016
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K940172 (1994). 20 ancestors in all, the oldest K871859 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 5 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 4 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 3 generations backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- 2 generations backK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- 1 generation backK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- This deviceK162112 Caas MRVPie Medical Imaging BV · 2016
- Descendant · cites it directly · 1 of its ownK181825 CAAS MR SolutionsPie Medical Imaging BV · 2018
- Descendant · 2 generations on · 0 of its ownK232007 CAAS MR SolutionsPie Medical Imaging BV · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −5 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −4 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −3 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| −2 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| −1 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| 0 (this device) | K162112 | Caas MRV | Pie Medical Imaging BV | 2016 | — |
| +1 | K181825 | CAAS MR Solutions | Pie Medical Imaging BV | 2018 | — |
| +2 | 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 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K060941 | Caas MRV Version 3.0Summary page 4…ass: Class II Regulation number: 21 CFR 892.2050 Classification Product Code: LLZ Predicate Devices - CAAS MRV (K060941, Image Processing Systems, 21 CFR 892.2050, LLZ) - Medis MR-CT VVA (K140587, Image Processing Systems, 2… | 2006 |
| * | K140587 | MR-CT VvaSummary page 4…assification Product Code: LLZ Predicate Devices - CAAS MRV (K060941, Image Processing Systems, 21 CFR 892.2050, LLZ) - Medis MR-CT VVA (K140587, Image Processing Systems, 21 CFR 892.2050, LLZ) Device Description CAAS MRV is designed as a sta… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181825 | CAAS MR Solutions | 2018 | 1 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 20 ancestors have a recall of any class.
- Of its descendants, K181825 (Pie Medical Imaging BV, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K060941.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
CAAS MRV features segmentation of cardiovascular structures on different types of MR images as well as measurement and reporting tools to facilitate the following use:
* Quantitative functional and regional analyses of the heart ventricles
* Quantification of T2 and T2* relaxation values
CAAS MRV is intended to be used by or under supervision of a cardiologist or radiologist. When the results provided by CAAS MRV are used in a clinical setting to support diagnosis of cardiovascular conditions, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.
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/K162112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162112: 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/K162112
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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