21 C.F.R. § 892.5930 Therapeutic x-ray tube housing assembly.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 892.5930 Therapeutic x-ray tube housing assembly.