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510(k) Data Aggregation

    K Number
    K021154
    Device Name
    GOLDWAY PATIENT MONITOR, MODEL # UT4000F
    Manufacturer
    GOLDWAY US, INC.
    Date Cleared
    2003-04-11

    (366 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOLDWAY US, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The patient monitor is intended to monitor the basic physiological parameters of the patient under the direct supervision of a licensed healthcare practitioner. It can be used for all patients from Adult to Neonatal. The monitor is designed as a bedside or portable monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post-anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities. The UT 4000F is not intended for use as an apnea monitor. The UT 4000F is not intended for use during MRI or CT scans. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, non-invasive blood pressure, pulse, temperature, respiration, pulse oximetry, and carbon dioxide. The UT 4000F Patient Monitor is also intended to provide physiological data over a network to clinical information systems and allow the user to access hospital data at the point of care.
    Device Description
    Not Found
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    K Number
    K021153
    Device Name
    GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
    Manufacturer
    GOLDWAY US, INC.
    Date Cleared
    2003-02-10

    (306 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOLDWAY US, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Goldway Digital Video Colposcope Imaging System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color screen, printed on a color printer or archived for storage and subsequent retrieval. The device is intended for use in Hospitals and clinics.
    Device Description
    The Goldway Digital Video Colposcope Imaging Systems, SLC-2000A and SLC-2000B are intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The SLC-2000A consists of a ¼' Super HAD CCD color camera and image management workstation. Tissue is magnified and viewed directly either via a 5.6" LCD screen attached to the capture device or on the 14'' color monitor attached to the image workstation. The SLC-2000B contains the same capture device but does not include the image workstation. Images can only be viewed via the 5.6'' LCD screen with this model. The images provide recorded documentation for the physician or nurse practitioner to review for diagnostic purposes. The Goldway Colposcopes have a non-patient contact of up to 350mm. Both colposcopes have the option of being equipped with a Dermatology and Venereal Disease application kit and Dynamic White Polarization kit. The Goldway Colposcopes, SLC-2000A and SLC-2000B are a non-patient contacting CCD color camera with a magnification of x1 ~ x28, working distances supporting 150-350mm, and a green filtered light source mounted on a floor stand. The SLC-2000B also comes with an image workstation which consists of a CCD camera, computer, LCD monitor, a mouse, a keyboard and color printer. The functions of the image management workstation include: - Storing digital images for viewing during the colposcopy exam, and for printing and/or later review - Storing textual information about a patient's medical history related to colposcopy - Storing textual information about observations seen during a colposcopy examination - Printing a colposcopy report that integrates images and textual information
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