# K161146: Radixact Treatment Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Jun 24, 2016 after 63 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K914698 (1992). 27 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121934: Tomotherapy Treatment System, Accuray Incorporated (2012) Summary page 4.

## Most influential descendants
- K202412: ClearRT Helical kVCT for the Radixact Treatment Delivery System (2020), 1 descendant of its own
- K223159: Radixact Treatment Delivery System (2023), 0 descendants of its own
- K182687: Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System (2018), 0 descendants of its own

## Recalls of this device
- Aug 3, 2023 · Class II · Z-2489-2023: It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the syst

## Indications for use
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/K161146
Methodology: https://510kreport.com/methodology