← Product Code [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ) · K091598

# LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS (K091598)

_Nucletron Corp. · JAQ · Jun 29, 2009 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K091598

## Device Facts

- **Applicant:** Nucletron Corp.
- **Product Code:** [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ.md)
- **Decision Date:** Jun 29, 2009
- **Decision:** SESE
- **Submission Type:** Special
- **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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K091598](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K091598)

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