Product code NWE

Device name

Colon Computed Tomography System, Computer Aided Detection

Medical specialty

Radiology

Device class

2

Regulation number

892.2050

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset