OMJ

Chest X-Ray Computer Aided Detection

Product code

OMJ

Device name

Chest X-Ray 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)

1 (all years; only the last 3 years are listed here)

FDA classification definition

To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.

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