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Axxent Electronic Brachytherapy System

by Xoft, Inc. 510(k)

Active United States

510(k) K050843

Overview

The Axxent Electronic Brachytherapy System is a therapeutic X-ray system used in radiology for the delivery of electronic brachytherapy. It is designed to provide targeted radiation treatment using a miniaturized X-ray source.

The system is supplied as a reusable device and is FDA cleared under 510(k) K050843. It is intended for use in standard clinical settings such as outpatient consultation rooms and operating theatres, requiring minimal shielding due to its compact design and built-in safety features.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK050843 Date22 Dec 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JAD
Device Class
Class II
Regulation
21 CFR Part 892.5900
Advisory Committee
Radiology
FDA Decision
SESU

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