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510(k) Data Aggregation

    K Number
    K152402
    Device Name
    IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
    Manufacturer
    Date Cleared
    2016-03-04

    (192 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    SECURUS,INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IRTS Probe is intended for continuous esophageal temperature monitoring. The IRTS Patient Monitoring Unit Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.
    Device Description
    The Securus InfraRed Thermographic System (IRTS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on a monitor for the user. The InfraRed Thermographic System (IRTS) consists of three components: - A. Thermal Imaging Probe (TIP or Probe) - B. Patient Interface Unit (PIU) - C. Patient Monitoring Unit (PMU) The Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. In addition, the IRTS incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The thermal data is presented on the Patient Monitoring Unit as a two-dimensional color map with peak temperature over the mapped area. The thermal image and peak temperature are offered as additional temperature monitoring features.
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