FDA Product Code OEB: Lung Computed Tomography System, Computer-aided Detection
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.
Leading manufacturers include Siemens Healthcare GmbH, Coreline Soft Co., Ltd. and Infervision Medical Technology Co., Ltd..
FDA 510(k) Cleared Lung Computed Tomography System, Computer-aided Detection Devices (Product Code OEB)
About Product Code OEB - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code OEB since 2003, with 19 receiving FDA clearance (average review time: 142 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under OEB have taken an average of 285 days to reach a decision - up from 115 days historically. Manufacturers should account for longer review timelines in current project planning.
OEB devices are reviewed by the Radiology panel. Browse all Radiology devices →