Lung Computed Tomography System, Computer-Aided Detection

What Is It?

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.

What Is FDA Product Code OEB?

Lung Computed Tomography System, Computer-Aided Detection is FDA product code OEB, Class 2, 21 CFR 892.2050.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 355 days from receipt to decision on them.