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Cesitrx Liquid CESIUM-131 Solution for Use With Gliasite Rts

by Isoray, Inc.

510(k) K132996

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)SESE Substantially Equivalent · Traditional NumberK132996 Date17 Dec 2013ClearedStatusActive

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  • Withdrawn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
KXK
Device Class
Class II
Regulation
21 CFR Part 892.5730
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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.

Cesitrx is a radionuclide brachytherapy source consisting of a liquid Cesium-131 solution. It is designed for use with the Gliasite RTS, a brachytherapy system intended for the treatment of malignant brain tumors by delivering radiation into a resected tumor cavity.

This device is supplied for use with the Gliasite RTS system, which includes a double-balloon catheter available in 2, 3, and 4 cm sizes. The product has received FDA 510(k) clearance under K132996.

Other devices from Isoray, 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 primary clinical use of Cesitrx?

    Cesitrx is a radionuclide brachytherapy source consisting of a liquid Cesium-131 solution. It is specifically designed to be used in conjunction with the Gliasite RTS system to deliver radiation therapy directly into a resected tumor cavity for the treatment of malignant brain tumors.

  • How is the Gliasite RTS system configured for use with Cesitrx?

    The Gliasite RTS system, which is used to administer the Cesitrx solution, includes a double-balloon catheter. This catheter is available in three distinct sizes—2 cm, 3 cm, and 4 cm—to accommodate the specific dimensions of the resected tumor cavity.

  • What is the regulatory status of this device?

    Cesitrx has received FDA 510(k) clearance under the submission number K132996. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices for its intended use in brachytherapy.