← Product Code [KPQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPQ) · K834281

# RAD II SIMULATOR (K834281)

_Haynes Radiation Ltd., Inc. · KPQ · Dec 29, 1983 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPQ/K834281

## Device Facts

- **Applicant:** Haynes Radiation Ltd., Inc.
- **Product Code:** [KPQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPQ.md)
- **Decision Date:** Dec 29, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5840
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPQ/K834281](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPQ/K834281)

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