FDA product code ITZ

Assembly, Tube Housing, X-Ray, Therapeutic

RadiologyClass 221 CFR 892.5930

Verified

US regulatory classifications

US Product Code (FDA): ITZ
US Risk Class (FDA): Class 2
US Regulation (CFR): 21 CFR 892.5930
Medical specialty: Radiology

Device characteristics

GMP exempt: No
Implantable: No
Life-sustaining: No
Third party review: Eligible

Search keywords

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01X-ray tube 02X-ray housing 03Therapeutic X-ray 04Radiation therapy 05Linear accelerator 06Linac X-ray 07Oncology X-ray 08Radiation shield 09X-ray component 10Radiation source

About this record

Assembly, Tube Housing, X-Ray, Therapeutic 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.