BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ExactVu High Resolution Micro-Ultrasound System

    K Number: K192303 · Decision Oct 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    3
    Review Days
    39

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    Basic Information

    Device Name
    ExactVu High Resolution Micro-Ultrasound System
    K Number
    K192303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exact Imaging, Inc.
    Date Received
    August 23, 2019
    Decision Date
    October 1, 2019
    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 Exact Imaging, Inc.

    K Number Device Name
    K190995 ExactVu High Resolution Micro-Ultrasound System
    K180636 ExactVu High Resolution Micro-Ultrasound System