FDA product code OMJ

Chest X-Ray Computer Aided Detection

Radiology·Class 2·21 CFR 892.2050
US regulatory classifications
US Product Code (FDA)
OMJ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 892.2050
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Medical specialty
Radiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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

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About this record

Chest X-Ray Computer Aided Detection is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.