OEB · Class II · 21 CFR 892.2050

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.

2
Total
2
Cleared
116d
Avg days
2021
Since

List of Lung Computed Tomography System, Computer-aided Detection devices cleared through 510(k)

2 devices
1–2 of 2

How to use this database

This page lists all FDA 510(k) submissions for Lung Computed Tomography System, Computer-aided Detection devices (product code OEB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →