# K250392: ZAP-X Radiosurgery System (ZAP-X)

- Pathway: 510(k) (Traditional)
- Applicant: Zap Surgical Systems, Inc.
- Decided: Nov 3, 2025 after 264 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: 4 generations back to K150873 (2015). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211663: Zap-X Radiosurgical System, Zap Surgical Systems, Inc. (2021) Summary page 5.

## Indications for use
The ZAP-X Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions in the brain, head and neck when radiation treatment is indicated.

Source page: https://510kreport.com/device/K250392
Methodology: https://510kreport.com/methodology