510(k) · Cleared
Recalled · Class II · 2024Synapse Cardiovascular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical Systems U.S.A, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 12, 2015 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 12, 2015
- Review
- 35 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK151859 Synapse CardiovascularFujifilm Medical Systems U.S.A, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK190232 Synapse PACSFujifilm Corporation · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK261713 Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK192508 Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K190232Synapse PACSFujifilm Corporation · 2019 · cites it directly3descendants
- K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025 · 2 generations on1descendant
- K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026 · 3 generations on0descendants
- K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K151859 | Synapse Cardiovascular | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| +1 | K190232 | Synapse PACS | Fujifilm Corporation | 2019 | 11 |
| +2 | K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +3 | K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026 | — |
| +2 | K192508 | Medsynapse Ris Pacs & Medsynapse VNA | Medsynaptic Private, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190232 | Synapse PACS | 2019 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2024 | Class II | Z-1172-2024 | Software design | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a… |
| Apr 30, 2021 | Class II | Z-1775-2021 | Software design | Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K190232 (Fujifilm Corporation, 2019) has gone furthest, with 3 descendants 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. 2015, 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 | — |
https://510kreport.com/device/K151859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151859: Synapse Cardiovascular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151859
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026