510(k) · Cleared
ClearedCAAS MR 4D Flow
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 Dec 8, 2016 as substantially equivalent to K133937 (Morpheus Imaging, Inc., 2014) after a 106-day review. Its family tree reaches back 5 generations to 2001. 3 later devices descend from it.
- Decided
- Dec 8, 2016
- Review
- 106 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010938 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 4 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK042203 Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK103565 Medvoxel Heartpro Software ApplicationMedvoxel Systems, Inc. · 2011
- 1 generation backK133937 Heartscan SoftwareMorpheus Imaging, Inc. · 2014
- This deviceK162376 CAAS MR 4D FlowPie 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
- Descendant · cites it directly · 0 of its ownK191544 Synapse 3D Blood Flow AnalysisFujifilm Corporation · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −4 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −3 | K042203 | Leonardo Syngo Cardiology Workstation | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K103565 | Medvoxel Heartpro Software Application | Medvoxel Systems, Inc. | 2011 | — |
| −1 | K133937 | Heartscan Software | Morpheus Imaging, Inc. | 2014 | — |
| 0 (this device) | K162376 | CAAS MR 4D Flow | 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 | — |
| +1 | K191544 | Synapse 3D Blood Flow Analysis | Fujifilm Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K133937 | Heartscan SoftwareSummary page 4…Regulation number: 21 CFR 892.2050 Classification Product Code: LLZ Predicate Device Morpheus HeartScan (K133937, Image Processing System, 21 CFR 892.2050, LLZ) Device Description CAAS MR 4D Flow offers functionality to import images; to ana… | 2014 |
What descends from it? (3)
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 15 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 5 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 K133937.
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 MR 4D Flow enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images by providing the following functionality:
» Segmentation of cardiovascular structures;
* Visualization of blood flow velocity and directions;
* Calculation of quantitative cardiovascular results.
When the results provided by CAAS MR 4D Flow 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162376: CAAS MR 4D Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162376
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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