← Product Code [IZG](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG) · K892659

# ELECTRODELCA (K892659)

_Oldelft Corp. of America · IZG · Nov 21, 1989 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K892659

## Device Facts

- **Applicant:** Oldelft Corp. of America
- **Product Code:** [IZG](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG.md)
- **Decision Date:** Nov 21, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1730
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Special Controls

*Classification.* Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K892659](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZG/K892659)

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