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) → IWA — Source, Wire, Iridium, Radioactive

# IWA · Source, Wire, Iridium, Radioactive

_Radiology · 21 CFR 892.5730 · Class 2_

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

## Overview

- **Product Code:** IWA
- **Device Name:** Source, Wire, Iridium, Radioactive
- **Regulation:** [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K915253](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K915253.md) | IR-192 IMPLANT, MODIFICATION | Omnitron Intl., Inc. | Feb 27, 1992 | SESE |
| [K894409](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K894409.md) | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD | Amersham Corp. | Sep 29, 1989 | SESE |
| [K874895](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K874895.md) | IR-192 IMPLANT | Rads S.L., Inc. | Feb 25, 1988 | SESE |
| [K850382](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K850382.md) | IRIDIUM SEEDS | Radiation Safety & Nuclear Products, Inc. | Aug 15, 1985 | SESE |
| [K844248](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K844248.md) | IR-192 IMPLANT | Rads S.L., Inc. | Apr 10, 1985 | SESE |
| [K850726](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K850726.md) | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Syncor Intl. Corp. | Mar 26, 1985 | SESE |
| [K850163](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K850163.md) | IRIDIUM 192 WIRES | Syncor Intl. Corp. | Mar 26, 1985 | SESE |
| [K771878](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWA/K771878.md) | IRIDIUM 192 WIRES & PINS | Cis Radiopharmaceuticals, Inc. | Oct 27, 1977 | SESE |

## Top Applicants

- Rads S.L., Inc. — 2 clearances
- Syncor Intl. Corp. — 2 clearances
- Amersham Corp. — 1 clearance
- Cis Radiopharmaceuticals, Inc. — 1 clearance
- Omnitron Intl., Inc. — 1 clearance

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

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