BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    SONON Ultrasound Imaging System, Model: 300L

    K Number: K170085 · Decision Oct 12, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    275

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    Basic Information

    Device Name
    SONON Ultrasound Imaging System, Model: 300L
    K Number
    K170085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healcerion Co., Ltd.
    Date Received
    January 10, 2017
    Decision Date
    October 12, 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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    Other Clearances by Healcerion Co., Ltd.

    K Number Device Name
    K211665 SONON Ultrasound Imaging System, Model: SONON300C
    K212400 SONON Ultrasound Imaging System, Model: SONON 500L
    K151339 SONON Ultrasound Imaging System (Model: SONON 300C)