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PRONEX Linear Accelerator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102765

by Direx Systems Corp.

Identifiers

510(k) Number
K102765 FDA 510(k)
FDA Product Code
IYE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PRONEX is a Linear Accelerator, a medical device designed to generate high-energy x-rays or electron beams for external beam radiotherapy. It delivers precise radiation doses to treat malignant tumors by accelerating electrons to high velocities within a linear accelerator structure, allowing controlled irradiation of targeted tissue while minimizing exposure to surrounding healthy areas.

The PRONEX is intended for use in radiology departments within hospital or clinic settings. It is supplied as a reusable, non-sterile device, with regulatory clearance under FDA 510(k) classification (IYE) and authorized under regulation 892.5050. The device operates within Class II classification and is intended for external beam radiotherapy applications, adhering to established safety and performance standards for linear accelerators.

Frequently asked questions

What is the primary purpose of the PRONEX Linear Accelerator in a clinical setting?

The PRONEX is designed to generate high-energy x-rays or electron beams for external beam radiotherapy, allowing precise delivery of radiation doses to malignant tumors while minimizing exposure to surrounding healthy tissue. It is specifically intended for use in radiology departments within hospitals or clinics to treat cancerous growths through controlled irradiation.

Is the PRONEX a single-use or reusable device, and what does that mean for maintenance?

The PRONEX is a reusable, non-sterile device, meaning it is built for repeated use in clinical settings after proper cleaning, calibration, and maintenance. Since it is not sterile, it must be handled according to established infection control protocols before each use, and regular servicing is required to ensure accurate radiation delivery and safety.

How was the PRONEX approved for clinical use, and what regulatory pathway was followed?

The PRONEX received FDA 510(k) clearance under the Traditional pathway, classified as substantially equivalent to a predicate device. It was reviewed by the Radiology (RA) Advisory Committee and authorized under regulation 892.5050, falling under Class II medical device classification. This means it underwent a premarket submission to demonstrate safety and performance before commercial distribution.

Where and how should the PRONEX be stored to maintain its functionality?

While the device specifications do not detail exact storage conditions, as a reusable medical device, the PRONEX should be stored in a clean, dry, and controlled environment—protected from dust, moisture, and extreme temperatures—to prevent damage to its mechanical and electronic components. Proper storage also ensures calibration stability and extends the device’s operational lifespan.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PRONEX (K102765) — FDA 510 (k) | Innolitics, PDF -7 Pronex 51 0(K) number 1( 2 6 - accessdata.fda.gov, Direx Systems Corp. - FDA 510 (k) Cleared Devices, Direx Pronex - allmed.wiki, Direx Systems Corp. · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Direx Systems Corp.

Sources (1)

  • FDA 510(k) K102765 24 fields · synced Sep 19, 2026