BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

    K Number: K230140 · Decision Apr 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    96

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    Basic Information

    Device Name
    TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
    K Number
    K230140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Compai Healthcare (Suzhou) Co.,Ltd
    Date Received
    January 18, 2023
    Decision Date
    April 24, 2023
    Product Code
    MWP
    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
    MWP Cabinet, X-Ray System

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    Other Clearances by Compai Healthcare (Suzhou) Co.,Ltd

    K Number Device Name
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