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

    Terason uSmart3200T Ultrasound System

    K Number: K193510 · Decision Jan 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    Terason uSmart3200T Ultrasound System
    K Number
    K193510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teratech Corporation
    Date Received
    December 18, 2019
    Decision Date
    January 28, 2020
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 Teratech Corporation

    K Number Device Name
    K201633 Terason uSmart 3200T Plus Ultrasound System