← Product Code [EAG](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG) · K896099

# DIGIGRAPH DIAGNOSTIC WORK/STATION (K896099)

_Dolphin Imaging Systems · EAG · Jan 31, 1991 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAG/K896099

## Device Facts

- **Applicant:** Dolphin Imaging Systems
- **Product Code:** [EAG](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAG.md)
- **Decision Date:** Jan 31, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.1830
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAG/K896099](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAG/K896099)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com