BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1

    K Number: K163702 · Decision May 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    1117
    Applicant Total
    58
    Review Days
    152

    Basic Information

    Device Name
    Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
    K Number
    K163702
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Date Received
    December 29, 2016
    Decision Date
    May 30, 2017
    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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