# K143560: CygneX I System

- Pathway: 510(k) (Traditional)
- Applicant: Accuthera, Inc.
- Decided: Oct 5, 2015 after 293 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: 2 generations back to K913174 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984563: The Cyberknife System for Stereotactic Radiosurgery/Radiotherapy, Accuray, Inc. (1999) Summary page 4.

## Indications for use
The CygneX I System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).

Source page: https://510kreport.com/device/K143560
Methodology: https://510kreport.com/methodology