# K203250: TaiChiC

- Pathway: 510(k) (Traditional)
- Applicant: Our United Corporation
- Decided: Mar 12, 2021 after 128 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 system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.

Source page: https://510kreport.com/device/K203250
Methodology: https://510kreport.com/methodology