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

    ROTATING GAMMA SYSTEM INFINI (INFINI)

    K Number: K102533 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    200

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    Basic Information

    Device Name
    ROTATING GAMMA SYSTEM INFINI (INFINI)
    K Number
    K102533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Masep Medical Science & Tech.Development (Shenzhen
    Date Received
    September 3, 2010
    Decision Date
    March 22, 2011
    Product Code
    IWB
    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
    IWB System, Radiation Therapy, Radionuclide

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