21 CFR § 892.5930
Therapeutic x-ray tube housing assembly
June 25, 2020
(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.
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