ZAP-X Radiosurgery System (ZAP-X)
Zap Surgical Systems, Inc.
ZAP SURGICAL SYSTEMS INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012039133 | 3012039133 | ZAP SURGICAL SYSTEMS INC. | 1 | N | 2026-01-01 | 590 Taylor Way San Carlos CA US 94070 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 221502 | 1852381811 | K250392 | ZAP-X Radiosurgery System (ZAP-X) | IYE | 2025-11-03 |
| 221502 | 1660474367 | K211663 | Zap-X Radiosurgical System | IYE | 2021-07-29 |
| 221502 | 1946117590 | K171804 | Zap-X Radiosurgery System | IYE | 2017-09-21 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYE | 3 | 2025-11-03 |
PMN#
Zap-X Radiosurgical System
Zap Surgical Systems, Inc.
Zap-X Radiosurgery System
Zap Surgical Systems
Zap-X Radiosurgery System
Zap Surgical Systems
GUDID#
Kit, Container, Fixation Pins, Immobilizer - An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session.
2025-11-17
DoseGuard - The ZAP-X includes an integrated transit dosimetry system, referred to as DoseGuard. This system provides an extra layer of patient safety by comparing measured and planned exit fluence and pausing the delivery if a deviation is detected.
2025-11-17
ZAP-Axon Treatment Planning System - The dedicated software application used to create, optimize, and review treatment plans for the ZAP-X Radiosurgery System. It provides the functionalities for the import, registration, and fusion of imaging studies, the delineation of target volumes and organs at risk (OARs), the calculation and optimization of the radiation dose, and the creation of planning reports. The application is installed on dedicated workstations that are directly connected to the other ZAP-X components.
2025-11-17
Kit, Container, Head Immobilizer - An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session.
2025-11-17
PinZ Patient Immobilizer - An optional accessory designed for rigid head immobilization. The device consists of a frame that is attached to the patient table and fixation pins that are affixed to the patient's head to minimize voluntary and involuntary patient movement and maintain the target position throughout the treatment session.
2025-11-17
Zap-X Radiosurgery System - The self-shielded ZAP-X® Radiosurgery System is a computer-controlled system for planning and delivering non-invasive stereotactic radiosurgery for tumors, lesions and conditions in the brain, head, and neck when radiation treatment is indicated. The system is self-shielded for ionizing radiation, allowing it to be installed in a non-bunker environment. A linear accelerator mounted on a dual-gantry provides a therapeutic radiation source, and a kV imaging system is used to locate and track the treatment target throughout the treatment.
2018-08-29
Zap-X MV Imager - The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
2018-08-29
Zap-X Treatment Planning Software - The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
2018-08-29
Zap-X Treatment Delivery Software - The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
2018-08-29