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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ITZ | Assembly, Tube Housing, X-Ray, Therapeutic | 2 | 0 | 3rd Party |