Lung Computed Tomography System, Computer-Aided Detection

OEB is the FDA product code for Lung Computed Tomography System, Computer-Aided Detection, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 20 510(k) clearances under this code, the most recent dated 2026-05-27, and no recalls.