← Product Code [ITY](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY) · K000052

# X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (K000052)

_Dynarad Corp. · ITY · Feb 10, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K000052

## Device Facts

- **Applicant:** Dynarad Corp.
- **Product Code:** [ITY](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY.md)
- **Decision Date:** Feb 10, 2000
- **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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K000052](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITY/K000052)

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