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510(k) Data Aggregation

    K Number
    K163140
    Device Name
    SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
    Manufacturer
    GEMSS MEDICAL SYSTEMS CO., LTD
    Date Cleared
    2017-05-26

    (198 days)

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

    GEMSS MEDICAL SYSTEMS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.
    Device Description
    The SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended to be used for mammography applications. SPINEL 12HD is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.
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    K Number
    K160065
    Device Name
    GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
    Manufacturer
    GEMSS MEDICAL SYSTEMS CO., LTD
    Date Cleared
    2016-05-20

    (128 days)

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

    GEMSS MEDICAL SYSTEMS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KMC-650 Surgical Mobile Fluoroscopic X-ray System is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not intended for interventional guided procedure & mammographic applications.
    Device Description
    The KMC-650 Surgical Mobile Fluoroscopic X-rav System consists of a high voltage (HV) inverter generator. a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. Not to be used for mammography. KMC-650 is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.
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    K Number
    K133695
    Device Name
    TITAN 11
    Manufacturer
    GEMSS MEDICAL SYSTEMS CO., LTD
    Date Cleared
    2014-08-07

    (247 days)

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

    GEMSS MEDICAL SYSTEMS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TITAN 11 is a diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. This device is not intended for mammography.
    Device Description
    TITAN 11, the high frequency inverter type of Radiographic system is operated by the built-in operation program. TITAN 11 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the SSXI detector, X-ray Generator, X-ray Collimator, PC, Detector Stand, Tube Stand, Mobile Table, PU-30(Power Supply) and viewing software. Optional devices include AEC, DAP, Hand or Foot Exposure Switch.
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