# K221539: GammaTile

- Pathway: 510(k) (Traditional)
- Applicant: Gt Medical Technologies
- Decided: Nov 9, 2022 after 166 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: 10 generations back to K801748 (1980). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190839: GammaTile, Gt Medical Technologies (2020) Summary page 4.

## Indications for use
GammaTile is indicated as a treatment for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms.

Source page: https://510kreport.com/device/K221539
Methodology: https://510kreport.com/methodology