← Product Code [IZO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO) · K953831

# N 800 HF (K953831)

_Nucletron-Oldelft Corp. · IZO · Sep 8, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K953831

## Device Facts

- **Applicant:** Nucletron-Oldelft Corp.
- **Product Code:** [IZO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO.md)
- **Decision Date:** Sep 8, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1700
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K953831](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZO/K953831)

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