# K190296: GammaTile

- Pathway: 510(k) (Special)
- Applicant: Gt Medical Technologies
- Decided: Mar 13, 2019 after 30 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: 8 generations back to K801748 (1980). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180515: GammaTile, Isoray Medical, Inc. (2018) Summary page 5.

## Most influential descendants
- K190839: GammaTile (2020), 1 descendant of its own
- K221539: GammaTile (2022), 0 descendants of its own

## Indications for use
GammaTile is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.

Source page: https://510kreport.com/device/K190296
Methodology: https://510kreport.com/methodology