Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730) → IWG — Seed, Isotope, Gold, Titanium, Platinum

# IWG · Seed, Isotope, Gold, Titanium, Platinum

_Radiology · 21 CFR 892.5730 · Class 2_

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

## Overview

- **Product Code:** IWG
- **Device Name:** Seed, Isotope, Gold, Titanium, Platinum
- **Regulation:** [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **Implant:** yes

## Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

## Classification Rationale

Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K081066](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWG/K081066.md) | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 | Medi-Physics, Inc., Dba GE Healthcare | May 5, 2008 | SESE |
| [K982421](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWG/K982421.md) | IMAGYN 125 I SEED, MODEL IS 125 | International Isotopes, Inc. | Jul 31, 1998 | SESE |
| [K834027](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWG/K834027.md) | GOLD SEADS | Radiation Safety & Nuclear Products, Inc. | Dec 27, 1983 | SESE |

## Top Applicants

- International Isotopes, Inc. — 1 clearance
- Medi-Physics, Inc., Dba GE Healthcare — 1 clearance
- Radiation Safety & Nuclear Products, Inc. — 1 clearance

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

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