Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5750](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5750) → IWD — Device, Beam Limiting, Teletherapy, Radionuclide

# IWD · Device, Beam Limiting, Teletherapy, Radionuclide

_Radiology · 21 CFR 892.5750 · Class 2_

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

## Overview

- **Product Code:** IWD
- **Device Name:** Device, Beam Limiting, Teletherapy, Radionuclide
- **Regulation:** [21 CFR 892.5750](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5750)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964607](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWD/K964607.md) | THERATON 1000E | Theratronics, Inc. | May 28, 1997 | SESE |

## Top Applicants

- Theratronics, Inc. — 1 clearance

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

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