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

    Digital Radiography System (ManntiX B, ManntiX K)

    K Number: K240841 · Decision Dec 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    257

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    Basic Information

    Device Name
    Digital Radiography System (ManntiX B, ManntiX K)
    K Number
    K240841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Browiner Tech Co., Ltd.
    Date Received
    March 27, 2024
    Decision Date
    December 9, 2024
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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    Other Clearances by Shenzhen Browiner Tech Co., Ltd.

    K Number Device Name
    K240284 Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)