# K200050: Akesis Galaxy RTx

- Pathway: 510(k) (Special)
- Applicant: Akesis, Inc.
- Decided: Feb 4, 2020 after 25 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- 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 K970647 (1997). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190844: Akesis Galaxy, Akesis, Inc. (2019) Summary page 4.

## Most influential descendants
- K203250: TaiChiC (2021), 0 descendants of its own
- K203146: Akesis Galaxy RTi (2021), 0 descendants of its own

## Indications for use
The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.

Source page: https://510kreport.com/device/K200050
Methodology: https://510kreport.com/methodology