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

    RIC CONFORMAL SOURCE, MODEL 100

    K Number: K090321 · Decision May 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    107

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    Basic Information

    Device Name
    RIC CONFORMAL SOURCE, MODEL 100
    K Number
    K090321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ri Consultants, LLC
    Date Received
    February 9, 2009
    Decision Date
    May 27, 2009
    Product Code
    ONL
    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
    ONL Conformal Brachytherapy Source