510(k) · Cleared
ClearedSynapse 3D Blood Flow Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · LLZ System, Image Processing, Radiological
Cleared on Oct 18, 2019 as substantially equivalent to K162376 (Pie Medical Imaging BV, 2016) after a 129-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Oct 18, 2019
- Review
- 129 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010938 (2001). No later device cites it as a predicate yet.
- Root · 6 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 5 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK042203 Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004
- 3 generations backK103565 Medvoxel Heartpro Software ApplicationMedvoxel Systems, Inc. · 2011
- 2 generations backK133937 Heartscan SoftwareMorpheus Imaging, Inc. · 2014
- 1 generation backK162376 CAAS MR 4D FlowPie Medical Imaging BV · 2016
- This deviceK191544 Synapse 3D Blood Flow AnalysisFujifilm Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −5 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −4 | K042203 | Leonardo Syngo Cardiology Workstation | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −3 | K103565 | Medvoxel Heartpro Software Application | Medvoxel Systems, Inc. | 2011 | — |
| −2 | K133937 | Heartscan Software | Morpheus Imaging, Inc. | 2014 | — |
| −1 | K162376 | CAAS MR 4D Flow | Pie Medical Imaging BV | 2016 | — |
| 0 (this device) | K191544 | Synapse 3D Blood Flow Analysis | Fujifilm Corporation | 2019 | — |
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 |
|---|---|---|---|
| * | K162376 | CAAS MR 4D FlowSummary page 4…egulation Number: 21 CFR 892.2050 Device Class: Class II Panel: Radiology Predicate Devices: CAAS MR 4D Flow (K162376) Pie Medical Imaging B.V. 510(k) Summary… | 2016 |
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 18 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K162376.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Synapse 3D Blood Flow Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals, with tools to aid them in reading, interpreting, reporting, and treatment planning.
Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191544: Synapse 3D Blood Flow Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191544
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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