BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    OTOPLAN

    K Number: K220300 · Decision Jun 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    142

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    Basic Information

    Device Name
    OTOPLAN
    K Number
    K220300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cascination AG
    Date Received
    February 2, 2022
    Decision Date
    June 24, 2022
    Product Code
    QQE
    Advisory Committee
    Radiology
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QQE Image Management Software For Planning Of Otologic And Neurotologic Procedures

    Similar 510(k) Clearances

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    Other Clearances by Cascination AG

    K Number Device Name
    K242120 OTOPLAN
    K232022 CAS-One IR
    K203486 Otoplan
    K152473 CAS-One IR
    K143024 CAS-One Liver