BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZAP-X Radiosurgery System (ZAP-X)

    K Number: K250392 · Decision Nov 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    2
    Review Days
    264

    Basic Information

    Device Name
    ZAP-X Radiosurgery System (ZAP-X)
    K Number
    K250392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zap Surgical Systems, Inc.
    Date Received
    February 12, 2025
    Decision Date
    November 3, 2025
    Product Code
    IYE
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYE Accelerator, Linear, Medical

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    Other Clearances by Zap Surgical Systems, Inc.

    K Number Device Name
    K211663 Zap-X Radiosurgical System