510(k) · Cleared
Clearedsyngo.CT Lung CAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on May 12, 2015 as substantially equivalent to K063877 (Siemens Medical Solutions USA, Inc., 2006) after a 187-day review. Its family tree reaches back 1 generation to 2006. 18 later devices descend from it.
- Decided
- May 12, 2015
- Review
- 187 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063877 (2006). 18 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK063877 Syngo Lung CadSiemens Medical Solutions USA, Inc. · 2006
- This deviceK143196 syngo.CT Lung CADSiemens AG Medical Solutions · 2015
- Descendant · cites it directly · 6 of its ownK163341 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK193216 syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK173625 syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK161201 ClearRead CTRiverain Technologies, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK203258 syngo.CT Lung CADSiemens Healthcare GmbH · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017 · cites it directly6descendants
- K193216syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020 · cites it directly5descendants
- K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on5descendants
- K161201ClearRead CTRiverain Technologies, LLC · 2016 · cites it directly5descendants
- K203258syngo.CT Lung CADSiemens Healthcare GmbH · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063877 | Syngo Lung Cad | Siemens Medical Solutions USA, Inc. | 2006 | — |
| 0 (this device) | K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015 | — |
| +1 | K163341 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +1 | K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020 | — |
| +2 | K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +1 | K161201 | ClearRead CT | Riverain Technologies, LLC | 2016 | — |
| +2 | K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (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? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K163341 (Siemens Medical Solutions USA, Inc., 2017) has gone furthest, with 6 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. 2015, 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 syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may have been initially overlooked. The syngo.CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143196: syngo.CT Lung CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143196
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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