DeviceClearance

Product code OMJ— Radiology

IQQA-CHEST SOFTWARE PACKAGE

Classification name
Chest X-Ray Computer Aided Detection
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

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

Market context for product code OMJ

FDA has cleared 1 device under product code OMJ, all in 2004, filed by 1 applicant company. 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.

Top applicants under product code OMJ

Recent clearances under product code OMJ

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