510(k) · Cleared
ClearedSynapse Lung Nodule AI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on May 27, 2026 as substantially equivalent to K161201 (Riverain Technologies, LLC, 2016) after a 160-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- May 27, 2026
- Review
- 160 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913770 (1991). 145 ancestors in all, the oldest K862120 (1986). No later device cites it as a predicate yet.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 1 generation backK161201 ClearRead CTRiverain Technologies, LLC · 2016
- This deviceK254075 Synapse Lung Nodule AIFujifilm Corporation · 2026
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 1 generation backK161201 ClearRead CTRiverain Technologies, LLC · 2016
- This deviceK254075 Synapse Lung Nodule AIFujifilm Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −1 | K161201 | ClearRead CT | Riverain Technologies, LLC | 2016 | — |
| 0 (this device) | K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 8 | 0 |
| 2001 | 15 | 0 |
| 2002 | 11 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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 OEB? 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 OEB device
- #1 K240554 InferRead Lung CT.AIscore 12.6 · 12 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.
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 35 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 36 of the 145 ancestors have a recall of any class.
- 3 other devices also cite its predicate K161201.
How does its category compare?
All OEB devicesOEB Lung Computed Tomography System, Computer-Aided Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OEB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OEB
229in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OEB
No recall names OEB since 2007.
Adverse event reports per year · OEB
No MAUDE report names OEB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 229 | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Synapse Lung Nodule AI is a computer-assisted detection software device intended to be used as concurrent reader to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on the lung cancer screening population according to the lung cancer screening protocols. The Synapse Lung Nodule AI requires that both lungs be in the field of view. The Synapse Lung Nodule AI provides adjunctive information such…
Read the full statement (117 words)
The Synapse Lung Nodule AI is a computer-assisted detection software device intended to be used as concurrent reader to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on the lung cancer screening population according to the lung cancer screening protocols. The Synapse Lung Nodule AI requires that both lungs be in the field of view. The Synapse Lung Nodule AI provides adjunctive information such as bounding boxes, segmented contours, and measurement values, and is not intended to be used without the original CT series. The Synapse Lung Nodule AI is also not intended to be used for the differentiation of the detected regions between benign and malignant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254075: Synapse Lung Nodule AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254075
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026