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