10 devices · 9 companies · 2016 to 2026
Product code OEB: Lung Computed Tomography System, Computer-Aided Detection
10 devices under product code OEB, 2016 to 2026, from 9 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (10 of 10 here), the regulation, and MAUDE report counts by product code.
Lung Computed Tomography System, Computer-Aided Detection. 21 CFR 892.2050, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Synapse Lung Nodule AIK254075 · 510(k) | Fujifilm Corporation | Radiology | database entry | |
| AVIEW Lung Nodule CADK251203 · 510(k) | Coreline Soft Co.,Ltd | Radiology | database entry | |
| InferRead Lung CT.AIK240554 · 510(k) | Infervision Medical Technology Co., Ltd. | Radiology | database entry | |
| V5med Lung AIK242919 · 510(k) | V5med Inc. | Radiology | database entry | |
| syngo.CT Lung CADK231157 · 510(k) | Siemens Healthcare GmbH | Radiology | database entry | |
| AVIEW Lung Nodule CADK221592 · 510(k) | Coreline Soft Co.,Ltd. | Radiology | database entry | |
| syngo.CT Lung CADK203258 · 510(k) | Siemens Healthcare GmbH | Radiology | database entry | |
| InferRead Lung CT.AIK192880 · 510(k) | Beijing Infervision Technology Co.,Ltd. | Radiology | database entry | |
| syngo.CT Lung CADK193216 · 510(k) | Siemens Medical Solutions, Inc | Radiology | database entry | |
| ClearRead CTK161201 · 510(k) | RIVERAIN TECHNOLOGIES, LLC | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.