21 CFR 892.5930 — Assembly, Tube Housing, X-Ray, Therapeutic

Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5930

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
ITZAssembly, Tube Housing, X-Ray, Therapeutic203rd Party
Innolitics

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