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) → ONL — Conformal Brachytherapy Source

# ONL · Conformal Brachytherapy Source

_Radiology · 21 CFR 892.5730 · Class 2_

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

## Overview

- **Product Code:** ONL
- **Device Name:** Conformal Brachytherapy Source
- **Regulation:** [21 CFR 892.5730](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5730)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K090321](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/ONL/K090321.md) | RIC CONFORMAL SOURCE, MODEL 100 | Ri Consultants, LLC | May 27, 2009 | SESE |

## Top Applicants

- Ri Consultants, LLC — 1 clearance

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

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