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

    AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)

    K Number: K014168 · Decision Apr 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    20
    Review Days
    127

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    Basic Information

    Device Name
    AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
    K Number
    K014168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosound Esaote, Inc.
    Date Received
    December 19, 2001
    Decision Date
    April 25, 2002
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Biosound Esaote, Inc.

    K Number Device Name
    K023255 TECHNOS MP, MODEL AU6
    K020164 E-SCAN XQ
    K012728 E-SCAN MRI SYSTEM
    K010405 7230 ULTRASOUND IMAGING SYSTEM WITH TEI
    K010057 MODIFICATION TO ARTOSCAN M
    K001894 MODIFICATION TO E-SCAN
    K000931 AU5 ULTRASOUND IMAGING SYSTEM
    K000681 AU5, AU6
    K994369 7250 (MEGAS)
    K990968 E-SCAN
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