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) → KQA — Device, Beam Limiting, X-Ray, Therapeutic

# KQA · Device, Beam Limiting, X-Ray, Therapeutic

_Radiology · 21 CFR 892.5900 · Class 2_

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

## Overview

- **Product Code:** KQA
- **Device Name:** Device, Beam Limiting, X-Ray, Therapeutic
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K914784](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KQA/K914784.md) | PAPILLION PROCTOSCOPE | Oldelft Corp. of America | Jun 5, 1992 | SESE |
| [K885126](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KQA/K885126.md) | PHILIPS RT250 COLLIMATOR (PK8050) | Perkins Mfg. Co. | Jun 1, 1989 | SESE |
| [K844180](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KQA/K844180.md) | THE MCP-70-SE SYSTEM | Ellis Pharmaceutical Consulting, Inc. | Feb 1, 1985 | SESE |
| [K790168](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KQA/K790168.md) | COLLIMATOR, BILATERIAL | Cmsi | Feb 15, 1979 | SESE |

## Top Applicants

- Cmsi — 1 clearance
- Ellis Pharmaceutical Consulting, Inc. — 1 clearance
- Oldelft Corp. of America — 1 clearance
- Perkins Mfg. Co. — 1 clearance

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

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