Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5050](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5050) → IWM — Synchrotron, Medical

# IWM · Synchrotron, Medical

_Radiology · 21 CFR 892.5050 · Class 2_

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

## Overview

- **Product Code:** IWM
- **Device Name:** Synchrotron, Medical
- **Regulation:** [21 CFR 892.5050](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5050)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

## Classification Rationale

Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, 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 |
| --- | --- | --- | --- | --- |
| [K872369](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IWM/K872369.md) | LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM | Loma Linda University Medical Center | Feb 22, 1988 | SESE |

## Top Applicants

- Loma Linda University Medical Center — 1 clearance

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

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