510(k) · Cleared
ClearedSyngo Lung Cad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Oct 18, 2006 after a 6-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Oct 18, 2006
- Review
- 6 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK063877 Syngo Lung CadSiemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 18 of its ownK143196 syngo.CT Lung CADSiemens AG Medical Solutions · 2015
- Descendant · 2 generations on · 6 of its ownK163341 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK193216 syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK173625 syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK161201 ClearRead CTRiverain Technologies, LLC · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K143196syngo.CT Lung CADSiemens AG Medical Solutions · 2015 · cites it directly18descendants
- K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017 · 2 generations on6descendants
- K193216syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020 · 2 generations on5descendants
- K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on5descendants
- K161201ClearRead CTRiverain Technologies, LLC · 2016 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063877 | Syngo Lung Cad | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015 | — |
| +2 | K163341 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +2 | K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020 | — |
| +3 | K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K161201 | ClearRead CT | Riverain Technologies, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 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 K254075 Synapse Lung Nodule AIscore 14.4 · 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? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143196 | syngo.CT Lung CAD | 2015 | 18 |
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, K143196 (Siemens AG Medical Solutions, 2015) has gone furthest, with 18 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K063877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063877: Syngo Lung Cad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063877
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026