← Product Code [EHD](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD) · K000551

# IMAGE X-70 PLUS DENTAL X-RAY UNIT (K000551)

_Medical Device Consultants, Inc. · EHD · Mar 16, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHD/K000551

## Device Facts

- **Applicant:** Medical Device Consultants, Inc.
- **Product Code:** [EHD](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD.md)
- **Decision Date:** Mar 16, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 872.1800
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHD/K000551](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHD/K000551)

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