← Product Code [JAB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB) · K813032

# ZIKON 100 DIGITAL X-RAY SYSTEM (K813032)

_Kontron Instruments, Inc. · JAB · Nov 24, 1981 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB/K813032

## Device Facts

- **Applicant:** Kontron Instruments, Inc.
- **Product Code:** [JAB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB.md)
- **Decision Date:** Nov 24, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1660
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB/K813032](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB/K813032)

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