← Product Code [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ) · K800320

# CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. (K800320)

_Amersham Corp. · IWJ · Mar 25, 1980 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K800320

## Device Facts

- **Applicant:** Amersham Corp.
- **Product Code:** [IWJ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ.md)
- **Decision Date:** Mar 25, 1980
- **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/K800320](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWJ/K800320)

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