OEB — Lung Computed Tomography System, Computer-Aided Detection Class II
FDA product code OEB covers "Lung Computed Tomography System, Computer-Aided Detection", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OEB
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254075 | fujifilm corporation | Synapse Lung Nodule AI | May 27, 2026 |
| K251203 | coreline soft co | AVIEW Lung Nodule CAD | December 3, 2025 |
| K240554 | infervision medical technology co | InferRead Lung CT.AI | May 16, 2025 |
| K242919 | v5med | V5med Lung AI | March 27, 2025 |
| K231157 | siemens healthcare | syngo.CT Lung CAD (Version VD30) | July 19, 2023 |
| K221592 | coreline soft co | AVIEW Lung Nodule CAD | February 24, 2023 |
| K221612 | riverain technologies | ClearRead CT | December 5, 2022 |
| K203258 | siemens healthcare | syngo.CT Lung CAD | March 31, 2021 |
| K201501 | mevis medical solutions | Veolity | February 23, 2021 |
| K192880 | beijing infervision technology co | InferRead Lung CT.AI | July 2, 2020 |
| K193216 | siemens medi cal solutions | syngo.CT Lung CAD | March 9, 2020 |
| K161201 | riverain technologies | ClearRead CT | September 9, 2016 |
| K143196 | siemens ag medical solutions | syngo.CT Lung CAD | May 12, 2015 |
| K043617 | hologic | IMAGECHECKER CT CAD SOFTWARE SYSTEM | December 21, 2007 |
| K063877 | siemens medical solutions usa | SYNGO LUNG CAD | October 18, 2006 |
| K042694 | ge medical systems | ADVANCED LUNG ANALYSIS II | November 18, 2004 |
| K041807 | medicsight | LUNG CAR 1.1 | July 22, 2004 |
| K041380 | r2 technology | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR | June 8, 2004 |
| K033412 | medicsight | MEDICLUNG, RELEASE 1 | December 30, 2003 |
| K033374 | siemens ag medical solutions | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | November 6, 2003 |