ITZ · Assembly, Tube Housing, X-Ray, Therapeutic
Radiology · 21 CFR 892.5930 · Class 2
Overview
| Product Code | ITZ |
|---|---|
| Device Name | Assembly, Tube Housing, X-Ray, Therapeutic |
| Regulation | 21 CFR 892.5930 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
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.
Cleared Devices (0)
No cleared devices on record.
