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

    NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM

    K Number: K130308 · Decision Apr 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
    K Number
    K130308
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Aloka Medical, Ltd.
    Date Received
    February 7, 2013
    Decision Date
    April 5, 2013
    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 Hitachi Aloka Medical, Ltd.

    K Number Device Name
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    K123828 PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
    K122341 PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37