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

    MODULEAF

    K Number: K030609 · Decision Mar 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    3
    Review Days
    19

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    Basic Information

    Device Name
    MODULEAF
    K Number
    K030609
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mrc Systems GmbH
    Date Received
    February 26, 2003
    Decision Date
    March 17, 2003
    Product Code
    IXI
    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
    IXI Block, Beam-Shaping, Radiation Therapy

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    Other Clearances by Mrc Systems GmbH

    K Number Device Name
    K022307 KONRAD, MODEL V.2.0
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