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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    AXIR-CX

    K Number: K213520 · Decision Aug 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    2
    Review Days
    289

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    Basic Information

    Device Name
    AXIR-CX
    K Number
    K213520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radisen Co., Ltd.
    Date Received
    November 3, 2021
    Decision Date
    August 19, 2022
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by Radisen Co., Ltd.

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