# K180515: GammaTile

- Pathway: 510(k) (Traditional)
- Applicant: Isoray Medical, Inc.
- Decided: Jul 6, 2018 after 129 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: 7 generations back to K801748 (1980). 25 ancestors in all.
3 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)
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5, Isoray Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K190296: GammaTile (2019), 2 descendants of its own
- K190839: GammaTile (2020), 1 descendant of its own
- K221539: GammaTile (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K180515
Methodology: https://510kreport.com/methodology