# K193207: TaiChiA

- Pathway: 510(k) (Traditional)
- Applicant: Our United Corporation
- Decided: Aug 7, 2020 after 261 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K926449 (1995). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181032: Halcyon, Varian Medical Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- K210921: TaiChiB (2021), 0 descendants of its own

## Indications for use
TaiChiA, is a Medical Linear Accelerator intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors,and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K193207
Methodology: https://510kreport.com/methodology