← Product Code [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ) · K951052

# WEEKS APPLICATOR (K951052)

_Duke University Medical Center · IWJ · Aug 22, 1996 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K951052

## Device Facts

- **Applicant:** Duke University Medical Center
- **Product Code:** [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ.md)
- **Decision Date:** Aug 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5650
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A manual radionuclide applicator system is a manually operated device intended to apply 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/IWJ/K951052](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K951052)

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