# K211663: Zap-X Radiosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Zap Surgical Systems, Inc.
- Decided: Jul 29, 2021 after 58 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K150873 (2015). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183698: Zap-X Radiosurgery System, Zap Surgical Systems (2019) Summary page 5.

## Most influential descendants
- K250392: ZAP-X Radiosurgery System (ZAP-X) (2025), 0 descendants of its own

## Recalls of this device
- Jul 25, 2025 · Class II · Z-2639-2025: If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of spee
- Jul 5, 2022 · Class II · Z-1742-2022: Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray

## 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/K211663
Methodology: https://510kreport.com/methodology