# K223159: Radixact Treatment Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Jun 23, 2023 after 259 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 K914698 (1992). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202412: ClearRT Helical kVCT for the Radixact Treatment Delivery System, Accuray Incorporated (2020) Summary page 4.

## Indications for use
The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, non-rotational, intensity-modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) treatment techniques and using image-guided (IGRT) or non-image-guided workflows in accordance with the physician-approved plan. The Radixact Treatment Delivery System integrates Surface Guided Radiation Therapy (SGRT) for patient setup, patient position and motion monitoring, and breath-hold gating.

Source page: https://510kreport.com/device/K223159
Methodology: https://510kreport.com/methodology