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 Medi Cal Solutions, Inc. · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Mar 9, 2020 as substantially equivalent to K143196 (Siemens AG Medical Solutions, 2015) after a 109-day review. Its family tree reaches back 2 generations to 2006. 5 later devices descend from it.
- Decided
- Mar 9, 2020
- Review
- 109 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063877 (2006). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK063877 Syngo Lung CadSiemens Medical Solutions USA, Inc. · 2006
- 1 generation backK143196 syngo.CT Lung CADSiemens AG Medical Solutions · 2015
- This deviceK193216 syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK203258 syngo.CT Lung CADSiemens Healthcare GmbH · 2021
- Descendant · 2 generations on · 2 of its ownK221592 AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK251203 AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK242919 V5med Lung AIV5med, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231157 syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH · 2023
Most influential descendants
Showing 5 of 5 · See all- K203258syngo.CT Lung CADSiemens Healthcare GmbH · 2021 · cites it directly4descendants
- K221592AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2023 · 2 generations on2descendants
- K251203AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2025 · 3 generations on0descendants
- K242919V5med Lung AIV5med, Inc. · 2025 · 3 generations on0descendants
- K231157syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063877 | Syngo Lung Cad | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −1 | K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015 | — |
| 0 (this device) | K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020 | — |
| +1 | K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021 | — |
| +2 | K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2023 | — |
| +3 | K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2025 | — |
| +3 | K242919 | V5med Lung AI | V5med, Inc. | 2025 | — |
| +2 | K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K143196 | syngo.CT Lung CADSummary page 4…for Siemens Healthcare GmbH syngo.CT Lung CAD (Previously cleared as syngo.CT Lung CAD, K143196) Version VC30 510(k) for syngo.CT Lung CAD VC30 Page 1… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203258 | syngo.CT Lung CAD | 2021 | 4 |
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 14 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K203258 (Siemens Healthcare GmbH, 2021) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K143196.
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. 2020, 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 VC30 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 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 as stated in the FDA summary.
https://510kreport.com/device/K193216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193216: 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/K193216
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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