← Product Code [ITY](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY) · K910308

# X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 (K910308)

_Inmark Corp. · ITY · Mar 27, 1991 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K910308

## Device Facts

- **Applicant:** Inmark Corp.
- **Product Code:** [ITY](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY.md)
- **Decision Date:** Mar 27, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1760
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K910308](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K910308)

**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