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) → IWI — Source, Isotope, Sealed, Gold, Titanium, Platinum

# IWI · Source, Isotope, Sealed, Gold, Titanium, Platinum

_Radiology · 21 CFR 892.5730 · Class 2_

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

## Overview

- **Product Code:** IWI
- **Device Name:** Source, Isotope, Sealed, 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)
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K973363](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWI/K973363.md) | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 | Ml Strategies, Inc. | Jul 2, 1998 | SESE |
| [K940632](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWI/K940632.md) | I-125 RAPID STRAND | Medi-Physics Inc. Dba Nycomed Amersham Imaging | Sep 2, 1994 | SESE |
| [K912170](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWI/K912170.md) | RADIOACTIVE IODINE-125 SOURCES | Best Industries | Aug 9, 1991 | SESE |
| [K882449](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWI/K882449.md) | CESIUM 137 SOURCE, MODEL CSM-40 | Cis-Us, Inc. | Apr 14, 1989 | SESE |
| [K874787](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWI/K874787.md) | MODIFIED PALLADIUM SEED MODEL 100 | Theragenics Corp. | Dec 22, 1987 | SESE |
| [K852542](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWI/K852542.md) | PALLADIUM SEED MODEL 100 | Nuclear Medicine, Inc. | Jan 14, 1986 | SESE |

## Top Applicants

- Best Industries — 1 clearance
- Cis-Us, Inc. — 1 clearance
- Medi-Physics Inc. Dba Nycomed Amersham Imaging — 1 clearance
- Ml Strategies, Inc. — 1 clearance
- Nuclear Medicine, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com