BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VERIQA RT EPID 3D

    K Number: K252258 · Decision Apr 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    2
    Review Days
    268

    Basic Information

    Device Name
    VERIQA RT EPID 3D
    K Number
    K252258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
    Date Received
    July 21, 2025
    Decision Date
    April 15, 2026
    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 Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

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