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AXXENT BALLOON APPLICATOR - AB2034

by Xoft, Inc.

510(k) K090914

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK090914 Date16 Jul 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAD
Models / Variants
AB2034
Device Class
Class II
Regulation
21 CFR Part 892.5900
Advisory Committee
Radiology
FDA Decision
SESU

Overview

AI-generated summary, 22 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 Axxent Balloon Applicator is a Class II X-ray system designed to provide a conformal radiation dose to the tumor cavity while minimizing exposure to surrounding healthy tissue. It is manufactured by Xoft, Inc. and is available in multiple models including AB2034, AB2045, AB2056, AB2057E, and AB2067E.

The device is supplied as part of a therapeutic X-ray system and is regulated under FDA 510(k) clearance with product code JAD. It is intended for use in radiology applications and has been cleared for providing targeted radiation therapy to tumor cavities while sparing adjacent healthy tissue.

Other devices from Xoft, Inc.

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Axxent Balloon Applicator used for?

    The Axxent Balloon Applicator is a Class II X-ray system designed to provide a conformal radiation dose to the tumor cavity while minimizing exposure to surrounding healthy tissue. It is intended for use in radiology applications for targeted radiation therapy.

  • What models of the Axxent Balloon Applicator are available?

    The Axxent Balloon Applicator is available in multiple models including AB2034, AB2045, AB2056, AB2057E, and AB2067E. Each model is designed to meet specific clinical requirements while maintaining the same core functionality.

  • How is the Axxent Balloon Applicator supplied?

    The device is supplied as part of a therapeutic X-ray system. It is regulated under FDA 510(k) clearance with product code JAD, indicating it has been cleared for providing targeted radiation therapy to tumor cavities while sparing adjacent healthy tissue.

  • What is the regulatory status of the Axxent Balloon Applicator?

    The Axxent Balloon Applicator has received FDA 510(k) clearance with product code JAD. It is classified as a Class II device and is intended for use in radiology applications. The clearance was granted on July 16, 2009, with K number K090914.