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

    Clarius AI

    K Number: K222406 · Decision Jan 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    216
    Applicant Total
    11
    Review Days
    167

    Basic Information

    Device Name
    Clarius AI
    K Number
    K222406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarius Mobile Health Corp.
    Date Received
    August 9, 2022
    Decision Date
    January 23, 2023
    Product Code
    QIH
    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
    QIH Automated Radiological Image Processing Software

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    Other Clearances by Clarius Mobile Health Corp.

    K Number Device Name
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    K233955 Clarius OB AI
    K232257 Clarius Bladder AI
    K232704 Clarius Ultrasound Scanner
    K213436 Clarius Ultrasound Scanner
    K192107 Clarius Ultrasound Scanner
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    K172385 Clarius Ultrasound System
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