BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Rover

    K Number: K211423 · Decision May 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    Rover
    K Number
    K211423
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-X Limited
    Date Received
    May 7, 2021
    Decision Date
    May 21, 2021
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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