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

    AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

    K Number: K013886 · Decision May 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    168

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    Basic Information

    Device Name
    AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
    K Number
    K013886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Diagnostics, Inc.
    Date Received
    November 23, 2001
    Decision Date
    May 10, 2002
    Product Code
    NCS
    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
    NCS System, Imaging, Holography, Acoustic

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    Other Clearances by Advanced Diagnostics, Inc.

    K Number Device Name
    K023037 MID STREAM PREGNANCY TEST
    K013291 ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
    K001510 OS-2000 OPTICAL SONOGRAPHY SYSTEM