# K132996: Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite RTS

- Pathway: 510(k) (Traditional)
- Applicant: Isoray, Inc.
- Decided: Dec 17, 2013 after 84 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003206 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111931: Gliasite RTS, Isoray Medical, Inc. (2011) Summary page 1.

## Indications for use
The GliaSite RTS With Cesitrex, (Liquid 131 0S01), is intended to deliver intracavity, radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.

Source page: https://510kreport.com/device/K132996
Methodology: https://510kreport.com/methodology