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510(k) Data Aggregation

    K Number
    K083640
    Device Name
    DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D
    Manufacturer
    CHOONGWAE MEDICAL CORP.
    Date Cleared
    2009-06-29

    (202 days)

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

    CHOONGWAE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. The CXD-DR80D Digital X-ray Imaging System utilizes the FLAATZ 750 Detector, manufactured by DRTECH Co. (K080064)
    Device Description
    The digital X-ray imaging system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a wall stand unit, a bucky table unit, a detector, operating software, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems.
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    K Number
    K040910
    Device Name
    INFANT INCUBATOR, MODEL CHS-I1000
    Manufacturer
    CHOONGWAE MEDICAL CORP.
    Date Cleared
    2004-04-21

    (13 days)

    Product Code
    FMZ
    Regulation Number
    880.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOONGWAE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHS-i1000 Infant Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. The CHS-i1000 Infant Incubators can be used in two operating modes, such as Air Control Mode and Skin Control Mode. The CHS-i1000 incubator is not for the transport of the patient. The CHS-i1000 Infant Incubator has alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value. The CHS-i1000 Infant Incubator incorporates other features, such as humidification of the infant environment and tilting of the bed.
    Device Description
    The CHS-i1000 incubator provides a controlled temperature and humidity for infants. It is designed to minimize the effect of external heat loss on infants. The incubator is composed of 4 main elements namely, the hood, base, cabinet and controller. Together they measure W1000 x H1367 x D634mm. The foam based mattress that measures W690 x D370mm positions centrally within the confines of the hood. The mattress can also be raised at the head and foot end to a maximum incline of 12°. This is achieved by turning the handles that are located on each end of the base. The hood is made of a clear acrylic to permit clear visibility of the baby yet provide isolation for the baby. The hood comprised of access ports gives access to the baby without compromising the thermal environment. Four of the access ports(two on the front and two on the rear) allow for regular access by the caregiver. The other two access ports are in the form of iris ports with are used primarily for ventilator tubes and monitoring cables to be channeled into the hood to the baby. Pulling the mattress towards the caregiver can enhance access even further.
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