BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MAMMOPAD RADIOLUCENT CUSHION

    K Number: K062141 · Decision Sep 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    MAMMOPAD RADIOLUCENT CUSHION
    K Number
    K062141
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biolucent, Inc.
    Date Received
    July 27, 2006
    Decision Date
    September 13, 2006
    Product Code
    IYX
    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
    IYX Camera, Scintillation (Gamma)

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