OEB — Lung Computed Tomography System, Computer-Aided Detection Class II
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 |
|---|---|---|---|
| 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 |