Pure Global AI
FDA product code IYO

System, Imaging, Pulsed Echo, Ultrasonic

RadiologyClass 221 CFR 892.1560
US regulatory classifications
US Product Code (FDA)
IYO
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 892.1560
Medical specialty
Radiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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About this record

System, Imaging, Pulsed Echo, Ultrasonic 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.