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

    XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

    K Number: K233200 · Decision Nov 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    2
    Review Days
    49

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    Basic Information

    Device Name
    XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
    K Number
    K233200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GEMSS HEALTHCARE CO., LTD.
    Date Received
    September 28, 2023
    Decision Date
    November 16, 2023
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

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    Other Clearances by GEMSS HEALTHCARE CO., LTD.

    K Number Device Name
    K230800 XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50