510(k) · Cleared
Clearedsyngo.CT Lung CAD (Version VD30)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare GmbH · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Jul 19, 2023 as substantially equivalent to K203258 (Siemens Healthcare GmbH, 2021) after an 86-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Jul 19, 2023
- Review
- 86 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K063877 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK063877 Syngo Lung CadSiemens Medical Solutions USA, Inc. · 2006
- 3 generations backK143196 syngo.CT Lung CADSiemens AG Medical Solutions · 2015
- 2 generations backK193216 syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020
- 1 generation backK203258 syngo.CT Lung CADSiemens Healthcare GmbH · 2021
- This deviceK231157 syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K063877 | Syngo Lung Cad | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −3 | K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015 | — |
| −2 | K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020 | — |
| −1 | K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021 | — |
| 0 (this device) | K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | 2023 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203258 | syngo.CT Lung CADSummary page 4…ass II Product Code: OEB 4. Legally Marketed Predicate Device: Trade Name: syngo.CT Lung CAD (Version VD20) 510(k) Clearance: K203258 Clearance Date: March 31, 2021 Classification Name: Medical image management and processing system 510(k) f… | 2021 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K203258.
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. 2023, 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?
syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader…
Read the full statement (151 words)
syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of
solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor
examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may
be otherwise overlooked.
The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the
radiologist or as second reader after the radiologist has completed his/her initial read.
The syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or
fully calcified CAD findings are filtered out.
The software device is an algorithm which does not have its own user interface component for displaying of CAD marks.
The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231157: syngo.CT Lung CAD (Version VD30).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231157
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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