# K203146: Akesis Galaxy RTi

- Pathway: 510(k) (Traditional)
- Applicant: Akesis, Inc.
- Decided: Mar 5, 2021 after 135 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: 3 generations back to K970647 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200050: Akesis Galaxy RTx, Akesis, Inc. (2020) Summary page 4.

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

Source page: https://510kreport.com/device/K203146
Methodology: https://510kreport.com/methodology