NWE

Colon Computed Tomography System, Computer Aided Detection

Product code

NWE

Device name

Colon 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 (all years, FDA)

4 (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 colon and highlight potential polyps that the radiologist should review.

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