← Product Code [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ) · K913908

# OMNITRON GYN APPLICATOR SYSTEM (K913908)

_Omnitron Intl., Inc. · JAQ · Mar 6, 1992 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K913908

## Device Facts

- **Applicant:** Omnitron Intl., Inc.
- **Product Code:** [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ.md)
- **Decision Date:** Mar 6, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5700
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K913908](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K913908)

**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