510(k) · Cleared
ClearedAVIEW Lung Nodule CAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coreline Soft Co., Ltd. · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Dec 3, 2025 as substantially equivalent to K221592 (Coreline Soft Co., Ltd., 2023) after a 229-day review. Its family tree reaches back 5 generations to 2006.
- Decided
- Dec 3, 2025
- Review
- 229 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K063877 (2006). No later device cites it as a predicate yet.
- Root · 5 generations backK063877 Syngo Lung CadSiemens Medical Solutions USA, Inc. · 2006
- 4 generations backK143196 syngo.CT Lung CADSiemens AG Medical Solutions · 2015
- 3 generations backK193216 syngo.CT Lung CADSiemens Medi Cal Solutions, Inc. · 2020
- 2 generations backK203258 syngo.CT Lung CADSiemens Healthcare GmbH · 2021
- 1 generation backK221592 AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2023
- This deviceK251203 AVIEW Lung Nodule CADCoreline Soft Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K063877 | Syngo Lung Cad | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −4 | K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015 | — |
| −3 | K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020 | — |
| −2 | K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021 | — |
| −1 | K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2023 | — |
| 0 (this device) | K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K221592 | AVIEW Lung Nodule CADSummary page 5…2050 Product Code(s) OEB, LLZ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221592 AVIEW Lung Nodule CAD OEB Device Description Summary 21 CFR 807.92(a)(4) The AVIEW Lung Nodule CAD is a software product that de… | 2023 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K221592.
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. 2025, 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?
AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review of CT examinations of the chest for asymptomatic populations. AVIEW Lung Nodule CAD provides adjunctive information to alert the radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. AVIEW Lung Nodule CAD may be used as a second reader…
Read the full statement (113 words)
AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review of CT examinations of the chest for asymptomatic populations. AVIEW Lung Nodule CAD provides adjunctive information to alert the radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. AVIEW Lung Nodule CAD may be used as a second reader after the radiologist has completed their initial read. The algorithm has been validated using non-contrast CT images, the majority of which were acquired on Siemens SOMATOM CT series scanners; therefore, limiting device use to use with Siemens SOMATOM CT series is recommended.
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/K251203 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251203: AVIEW Lung Nodule CAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251203
Report an extraction error
Are you the manufacturer?
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