BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows

    K Number: K213731 · Decision May 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    15
    Review Days
    186

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    Basic Information

    Device Name
    EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
    K Number
    K213731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ever Fortune.Ai, Co., Ltd.
    Date Received
    November 26, 2021
    Decision Date
    May 31, 2022
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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