510(k) · Cleared
ClearedSynapse 3D Colon Analysis
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 Jan 22, 2013 as substantially equivalent to K040126 (Viatronix, Inc., 2004) after a 63-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 22, 2013
- Review
- 63 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954355 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −1 | K040126 | Viatronix V3D Colon, Revision 1.3 | Viatronix, Inc. | 2004 | — |
| 0 (this device) | K123566 | Synapse 3D Colon Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K040126 | Viatronix V3D Colon, Revision 1.3Summary page 2…05 -1 FUJIIFILM Medical Systems U.S.A., Inc. Synapse 3D Colon Analysis 510(k) Predicate Device: \tiatronix V3D3 Colon, Revision 1.3 (K0401 26), Viatronik Inc. Description of the Device Synapse 3D ismedical application software running on Windows server/client configurat… | 2004 |
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 3 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K040126.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Colon Analysis is medical imaging software used with Synapse 3D Base Tools to accept display, and process DICOM compliant 2D and 3D medical images acquired from CT for the purpose of viewing of a colon to detect polyps, masses, cancers, and other lesions. It is intended to be used by trained medical professionals in reading, interpreting, reporting, and screening. Addition to the general 2D and 3D image processing and measurement tools…
Read the full statement (122 words)
Synapse 3D Colon Analysis is medical imaging software used with Synapse 3D Base Tools to accept display, and process DICOM compliant 2D and 3D medical images acquired from CT for the purpose of viewing of a colon to detect polyps, masses, cancers, and other lesions. It is intended to be used by trained medical professionals in reading, interpreting, reporting, and screening.
Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Base Tools, Synapse 3D Colon Analysis provides custom workflows, UI, and reporting functions for colon analysis, including colon segmentation, detection of the centerline of colon, fly-through of the entire colon, various rendering and visualization of colon, comparing both prone and supine views, and electronic cleansing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123566: Synapse 3D Colon Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123566
Report an extraction error
Are you the manufacturer?
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