21 C.F.R. § 892.5930
Therapeutic x-ray tube housing assembly.
Cite as 21 C.F.R. § 892.5930 (2026)
(a)
Identification.
A therapeutic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing intended for use in radiation therapy. This generic type of device may include high-voltage and filament transformers or other appropriate components when contained in radiation-shielded housing.
(b)
Classification.
Class II.