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PRONEX Linear Accelerator

by Direx Systems Corp.

510(k) K102765

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102765 Date7 Dec 2010ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Pronex
510(k) Number
FDA product code
IYE
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

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