# K190844: Akesis Galaxy

- Pathway: 510(k) (Traditional)
- Applicant: Akesis, Inc.
- Decided: Sep 4, 2019 after 156 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: 1 generation back to K970647 (1997). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K970647: Our Rotating Gamma System, Our Scientific Intl., Inc. (1997) Summary page 4.

## Most influential descendants
- K200050: Akesis Galaxy RTx (2020), 2 descendants of its own
- K203250: TaiChiC (2021), 0 descendants of its own
- K203146: Akesis Galaxy RTi (2021), 0 descendants of its own

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

Source page: https://510kreport.com/device/K190844
Methodology: https://510kreport.com/methodology