← Product Code [MUH](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH) · K063837

# SIGMA M (K063837)

_Instrumentarium Dental, Palodex Group OY · MUH · Jul 2, 2007 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUH/K063837

## Device Facts

- **Applicant:** Instrumentarium Dental, Palodex Group OY
- **Product Code:** [MUH](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH.md)
- **Decision Date:** Jul 2, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUH/K063837](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUH/K063837)

**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