# K202412: ClearRT Helical kVCT for the Radixact Treatment Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Dec 18, 2020 after 116 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: 12 generations back to K914698 (1992). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161146: Radixact Treatment Delivery System, Accuray Incorporated (2016) Summary page 4.

## Most influential descendants
- K223159: Radixact Treatment Delivery System (2023), 0 descendants of its own

## Indications for use
The kVCT Imaging Feature is an option within the indications for use of the Radixact Treatment Delivery System. The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

Source page: https://510kreport.com/device/K202412
Methodology: https://510kreport.com/methodology