Product code OEB

Device name

Lung 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 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.

Source

FDA openFDA device classification dataset