BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    CAREMIBRAIN

    K Number: K232569 · Decision Sep 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    3
    Review Days
    28

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    Basic Information

    Device Name
    CAREMIBRAIN
    K Number
    K232569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Equipment For Medical Imaging, S.A.
    Date Received
    August 24, 2023
    Decision Date
    September 21, 2023
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by General Equipment For Medical Imaging, S.A.

    K Number Device Name
    K110601 SENTINELLA 102
    K092471 MODEL SENTINELLA 102