OEB
20 FDA 510(k) clearances · Product code
146 daysmedian time to decision
267 days90th percentile
20clearances measured
FDA profile
- Official device name
- Lung Computed Tomography System, Computer-Aided Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Synapse Lung Nodule AI (K254075) | Fujifilm Corporation | 2026-05-27 |
| AVIEW Lung Nodule CAD (K251203) | Coreline Soft Co., Ltd. | 2025-12-03 |
| InferRead Lung CT.AI (K240554) | Infervision Medical Technology Co., Ltd. | 2025-05-16 |
| V5med Lung AI (K242919) | V5med, Inc. | 2025-03-27 |
| syngo.CT Lung CAD (Version VD30) (K231157) | Siemens Healthcare GmbH | 2023-07-19 |
| AVIEW Lung Nodule CAD (K221592) | Coreline Soft Co., Ltd. | 2023-02-24 |
| ClearRead CT (K221612) | Riverain Technologies, Inc. | 2022-12-05 |
| syngo.CT Lung CAD (K203258) | Siemens Healthcare GmbH | 2021-03-31 |
| Veolity (K201501) | MeVis Medical Solutions AG | 2021-02-23 |
| InferRead Lung CT.AI (K192880) | Beijing Infervision Technology Co., Ltd. | 2020-07-02 |
| syngo.CT Lung CAD (K193216) | Siemens Medi Cal Solutions, Inc. | 2020-03-09 |
| ClearRead CT (K161201) | Riverain Technologies, LLC | 2016-09-09 |
| syngo.CT Lung CAD (K143196) | Siemens AG Medical Solutions | 2015-05-12 |
| IMAGECHECKER CT CAD SOFTWARE SYSTEM (K043617) | Hologic, Inc. | 2007-12-21 |
| SYNGO LUNG CAD (K063877) | Siemens Medical Solutions USA, Inc. | 2006-10-18 |
| ADVANCED LUNG ANALYSIS II (K042694) | GE Medical Systems | 2004-11-18 |
| LUNG CAR 1.1 (K041807) | Medicsight | 2004-07-22 |
| IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR (K041380) | R2 Technology, Inc. | 2004-06-08 |
| MEDICLUNG, RELEASE 1 (K033412) | Medicsight | 2003-12-30 |
| LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K033374) | Siemens AG Medical Solutions | 2003-11-06 |
Track OEB automatically
Every clearance here is in the API, with alerts when new ones post.