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510(k) Data Aggregation

    K Number
    K250392
    Device Name
    ZAP-X Radiosurgery System (ZAP-X)
    Manufacturer
    Zap Surgical Systems, Inc.
    Date Cleared
    2025-11-03

    (264 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K190844,K211663
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended 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.

    Device Description

    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.

    AI/ML Overview

    N/A

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