Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart F — Therapeutic Devices](/submissions/RA/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 892.5900](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5900) → IYI — Collimator, Orthovoltage, Therapeutic X-Ray

# IYI · Collimator, Orthovoltage, Therapeutic X-Ray

_Radiology · 21 CFR 892.5900 · Class 2_

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

## Overview

- **Product Code:** IYI
- **Device Name:** Collimator, Orthovoltage, Therapeutic X-Ray
- **Regulation:** [21 CFR 892.5900](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/892.5900)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## Identification

An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K914821](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYI/K914821.md) | CRS RADIATION BEAM SCANNER | Consolidated Radiation Services, Inc. | Dec 17, 1992 | SESE |
| [K900932](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYI/K900932.md) | 37-702 AND 37-703 PC RAINBOW | Victoreen, Inc. | Dec 5, 1990 | SESE |

## Top Applicants

- Consolidated Radiation Services, Inc. — 1 clearance
- Victoreen, Inc. — 1 clearance

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

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