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 Healthcare GmbH · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Mar 31, 2021 as substantially equivalent to K193216 (Siemens Medi Cal Solutions, Inc., 2020) after a 146-day review. Its family tree reaches back 3 generations to 2006. 4 later devices descend from it.
- Decided
- Mar 31, 2021
- Review
- 146 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063877 (2006). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK063877 Syngo Lung CadSiemens Medical Solutions USA, Inc. · 2006
- 2 generations backK143196 syngo.CT Lung CADSiemens AG Medical Solutions · 2015
- 1 generation backK193216 syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020
- This deviceK203258 syngo.CT Lung CADSiemens Healthcare GmbH · 2021
- Descendant · cites it directly · 2 of its ownK221592 AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK251203 AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242919 V5med Lung AIV5med, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK231157 syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH · 2023
Most influential descendants
Showing 4 of 4 · See all- K221592AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2023 · cites it directly2descendants
- K251203AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2025 · 2 generations on0descendants
- K242919V5med Lung AIV5med, Inc. · 2025 · 2 generations on0descendants
- K231157syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063877 | Syngo Lung Cad | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −2 | K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015 | — |
| −1 | K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020 | — |
| 0 (this device) | K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021 | — |
| +1 | K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2023 | — |
| +2 | K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2025 | — |
| +2 | K242919 | V5med Lung AI | V5med, Inc. | 2025 | — |
| +1 | K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193216 | syngo.CT Lung CADSummary page 5…510(k) for syngo.CT Lung CAD VD20 Page 1 © Siemens Healthcare GmbH, 2021 510(k) Clearance: K193216 Clearance Date: March 2020 Classification Name: Lung computed tomography system, computer-aided detection… | 2020 |
What descends from it? (4)
2 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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221592 (Coreline Soft Co., Ltd., 2023) has gone furthest, with 2 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. 2021, 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 and subsolid (part-solid and ground glass) 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 otherwise be overlooked. The syngo.CT Lung CAD device may be used as…
Read the full statement (131 words)
The syngo.CT Lung CAD device is a Computer-Aided Detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid (part-solid and ground glass) 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 otherwise be 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 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/K203258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203258: 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/K203258
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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