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) → KPZ — Generator, High Voltage, X-Ray, Therapeutic

# KPZ · Generator, High Voltage, X-Ray, Therapeutic

_Radiology · 21 CFR 892.5900 · Class 2_

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

## Overview

- **Product Code:** KPZ
- **Device Name:** Generator, High Voltage, 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K912249](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPZ/K912249.md) | PATIENT DOSE MONITOR | Theta Systems, Inc. | Aug 30, 1991 | SESE |
| [K860469](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPZ/K860469.md) | 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS | Victoreen, Inc. | Apr 16, 1986 | SESE |
| [K854410](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KPZ/K854410.md) | VERIFLEX | Old Delft Corp. of America | Feb 12, 1986 | SESE |

## Top Applicants

- Old Delft Corp. of America — 1 clearance
- Theta Systems, Inc. — 1 clearance
- Victoreen, Inc. — 1 clearance

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

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