BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Solas OR

    K Number: K213691 · Decision Dec 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    29

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    Basic Information

    Device Name
    Solas OR
    K Number
    K213691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cirdan Imaging, Ltd.
    Date Received
    November 23, 2021
    Decision Date
    December 22, 2021
    Product Code
    MWP
    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
    MWP Cabinet, X-Ray System

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