DeviceClearance

Product code NWE— Radiology

COLON CAR 1.2

Classification name
Colon Computed Tomography System, Computer Aided Detection
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NWE under 21 CFR 892.2050, via openFDA

Market context for product code NWE

FDA has cleared 4 devices under product code NWE between 2004 and 2014, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NWE

Recent clearances under product code NWE

Data sourced from openFDA. This site is unofficial and independent of the FDA.