BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    TRINITY/3D PROSTATE SUITE

    K Number: K170521 · Decision May 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    97

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    Basic Information

    Device Name
    TRINITY/3D PROSTATE SUITE
    K Number
    K170521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koelis
    Date Received
    February 22, 2017
    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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    Other Clearances by Koelis

    K Number Device Name
    K180970 Disposable guides KDNG00
    K171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
    K160357 TRINITY
    K141334 REUSABLE GUIDE
    K131448 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
    K100793 UROSTATION 3D PROSTATE SUITE