OEB

Lung Computed Tomography System, Computer-Aided Detection

Product code

OEB

Device name

Lung Computed Tomography System, Computer-Aided Detection

Device class

Class 2

21 CFR

21 CFR 892.2050

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

20 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-05-27.

4 summaries are archived here for direct download.