FDA product code QWO

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Radiology·Class 2·21 CFR 892.2085
US regulatory classifications
US Product Code (FDA)
QWO
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 892.2085
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Medical specialty
Radiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.

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About this record

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. 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.