FDA product code OEB

Lung Computed Tomography System, Computer-Aided Detection

Radiology·Class 2·21 CFR 892.2050
US regulatory classifications
US Product Code (FDA)
OEB
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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 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.

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About this record

Lung Computed Tomography System, 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.