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

    VisiRad XR

    K Number: K223133 · Decision Aug 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    304

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    Basic Information

    Device Name
    VisiRad XR
    K Number
    K223133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imidex, Inc.
    Date Received
    October 3, 2022
    Decision Date
    August 3, 2023
    Product Code
    MYN
    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
    MYN Analyzer, Medical Image

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