510(k) · Cleared
ClearedSynapse 3D Cerebral Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 4, 2011 after a 77-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Mar 4, 2011
- Review
- 77 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK103687 Synapse 3D Cerebral AnalysisFujifilm Medical System U.S.A., Inc. · 2011
- Descendant · cites it directly · 1 of its ownK120637 Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
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 |
|---|---|---|---|---|---|
| 0 (this device) | K103687 | Synapse 3D Cerebral Analysis | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| +1 | K120637 | Synapse 3D Brain Perfusion | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +2 | K162287 | Synapse 3D Perfusion Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K120637 | Synapse 3D Brain Perfusion | 2012 | 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?
- Of its descendants, K120637 (Fujifilm Medical System U.S.A., Inc., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Cerebral Analysis is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cerebral Analysis accepts DICOM compliant medical images acquired from CT. This product is not intended for use with or for the primary diagnostic interpretation of…
Read the full statement (120 words)
Synapse 3D Cerebral Analysis is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cerebral Analysis accepts DICOM compliant medical images acquired from CT.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to Synapse 3D Basic Tools, Synapse 3D Cerebral Analysis provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT), and Time To Peak (UTP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103687: Synapse 3D Cerebral Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103687
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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