# K111931: Gliasite RTS

- Pathway: 510(k) (Special)
- Applicant: Isoray Medical, Inc.
- Decided: Aug 5, 2011 after 28 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: 1 generation back to K003206 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003206: Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005, Proxima Therapeutics, Inc. (2001) Summary page 1.

## Most influential descendants
- K132996: Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite RTS (2013), 0 descendants of its own

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

Source page: https://510kreport.com/device/K111931
Methodology: https://510kreport.com/methodology