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510(k) Data Aggregation

    K Number
    K233200
    Device Name
    XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
    Date Cleared
    2023-11-16

    (49 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gemss Healthcare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    XPlus 35 Series (XPLUS 35. XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures. i.e. surgical interventions needing X-ray imaging and interventions inside and outside the operating room.
    Device Description
    XPLUS 35 Series (XPLUS 35, XPLUS 35FD), C-arm mobile, is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. XPLUS 35 Series (XPLUS 35, XPLUS 35FD) consist of X-ray tube, X-ray generator, C-arm including image receptor, monitor cart, medical monitor and accessories such as foot switch and hand switch.
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    K Number
    K230800
    Device Name
    XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
    Date Cleared
    2023-11-02

    (224 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gemss Healthcare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XVISION-525 diagnostic X-ray system is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.
    Device Description
    The XVISION-525 diagnostic X-Ray System (Models HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50) generates medical X-rays passing through the patient's body and a X-ray detector for producing radiographic images of the human anatomical structures. The XVISION-525 diagnostic X-ray system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and a x-ray tube, that operates on a high-frequency inverter method. The user can select or change x-ray parameters easily using the operator control console. The AEC (Automatic Exposure Control) is an optional function to give the user control of exposure factors which can be optimized for different types of detectors selected, film or digital. The XVISION-525 X-ray system does not include a detector.
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