FDA product code POK
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Radiology·Class 2·21 CFR 892.2060
US regulatory classifications
- US Product Code (FDA)
- POKView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 892.2060View CFR Regulation →
- Medical specialty
- Radiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Assist users in characterizing lesions identified on acquired medical images
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About this record
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer 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.