Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5300](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5300) → IWL — System, Radiation Therapy, Neutron, Medical

# IWL · System, Radiation Therapy, Neutron, Medical

_Radiology · 21 CFR 892.5300 · Class 2_

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

## Overview

- **Product Code:** IWL
- **Device Name:** System, Radiation Therapy, Neutron, Medical
- **Regulation:** [21 CFR 892.5300](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5300)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.

## Classification Rationale

Class II.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K063691](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWL/K063691.md) | NEUTRON THERAPY SYSTEM | Northern Illinois Univ. Outreach | Jan 31, 2007 | SESE |
| [K852804](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWL/K852804.md) | MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS | Medcyc. Corp. | Oct 15, 1985 | SESE |
| [K812337](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWL/K812337.md) | ISOCENTRIC NEUTRON THERAPY SYSTEMS | The Cyclotron Corp. | Oct 2, 1981 | SESE |
| [K811778](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWL/K811778.md) | MODEL 4100 14 MEV NEUTRON GEN. THERAPY | The Cyclotron Corp. | Jul 23, 1981 | SESE |

## Top Applicants

- The Cyclotron Corp. — 2 clearances
- Medcyc. Corp. — 1 clearance
- Northern Illinois Univ. Outreach — 1 clearance

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

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