Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5930](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5930) → ITZ — Assembly, Tube Housing, X-Ray, Therapeutic

# ITZ · Assembly, Tube Housing, X-Ray, Therapeutic

_Radiology · 21 CFR 892.5930 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/ITZ

## Overview

- **Product Code:** ITZ
- **Device Name:** Assembly, Tube Housing, X-Ray, Therapeutic
- **Regulation:** [21 CFR 892.5930](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5930)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/ITZ](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/ITZ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com