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510(k) Data Aggregation

    K Number
    K212412
    Device Name
    IRIS-XP
    Manufacturer
    Medicore Co., Ltd.
    Date Cleared
    2021-09-13

    (41 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medicore Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IRIS XP is a thermal based imaging device intended for measuring relative skin temperature generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. (for adjunctive use only) The IRIS XP provides for use with both laptop and desktop computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements. The patient populations include all assessment age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.
    Device Description
    IRIS-XP shows an image analysis on the display to measure the amount of infrared rays radiated from the patient. The appropriate color image according to the temperature difference is shown on the screen. The IRIS XP is intended for relative skin temperature measurements (temperature mapping) for adjunctive use only.
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    K Number
    K110374
    Device Name
    MAX PULSE SYSTEM
    Manufacturer
    MEDICORE CO., LTD.
    Date Cleared
    2011-06-13

    (124 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICORE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
    Device Description
    The device is to measure the heart rate with photoelectric measurement techniques. It is to be connected with a desktop PC or laptop PC. It is operated with a mouse or a keyboard of PC which is used to enter the patient information as well as to operate the system and review the resulting analysis.
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    K Number
    K073323
    Device Name
    SA-3000P
    Manufacturer
    MEDICORE CO., LTD.
    Date Cleared
    2007-11-29

    (2 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICORE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device provides noninvasive measurement of pulse waveform and heart rate by photoelectric plethysmography. The anatomical site for taking the measurement is the left index finger. The device is intended for use with patients age 18 years and older and with a weight of 100 lbs or greater. The device is indicated for use in hospitals, health care clinics and physicians' offices
    Device Description
    The device is a photoelectric plethysmograph with is used to estimate blood flow in a region of the body using photoelectric measurement techniques
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