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

    Clarius Ultrasound System

    K Number: K172385 · Decision Sep 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    12
    Review Days
    37

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    Basic Information

    Device Name
    Clarius Ultrasound System
    K Number
    K172385
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarius Mobile Health Corp.
    Date Received
    August 8, 2017
    Decision Date
    September 14, 2017
    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 Clarius Mobile Health Corp.

    K Number Device Name
    K253593 Clarius Ejection Fraction AI
    K250226 Clarius Median Nerve AI
    K243853 Clarius Prostate AI
    K233955 Clarius OB AI
    K232257 Clarius Bladder AI
    K232704 Clarius Ultrasound Scanner
    K222406 Clarius AI
    K213436 Clarius Ultrasound Scanner
    K192107 Clarius Ultrasound Scanner
    K180799 Clarius Ultrasound Scanner
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