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    K Number
    K142926
    Device Name
    iBreastExam
    Manufacturer
    UE LIFESCIENCES, INC.
    Date Cleared
    2015-04-23

    (197 days)

    Product Code
    NKA
    Regulation Number
    884.2990
    Why did this record match?
    Applicant Name (Manufacturer) :

    UE LIFESCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    iBreastExam™ device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam™ device is intended for use by a qualified healthcare professional trained in its use and is not for home use.
    Device Description
    The iBreastExam system consists of a group of hardware and software components. The hardware component(s) consist of: iBreastExam Scanhead, Computer System, USB Wall Charger and Charging Cables. The software component(s) consist of: iBEConnect Software Program.
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    K Number
    K113259
    Device Name
    NOTOUCH BREASTSCAN
    Manufacturer
    UE LIFESCIENCES, INC.
    Date Cleared
    2012-02-10

    (98 days)

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

    UE LIFESCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NoTouch BreastScan system is intended to be used as an adjunctive screening device for the detection of breast cancer by measuring various temperature parameters from the surface of the breast. The NoTouch BreastScan™ system is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel. The patient include adult. The device is for adjunctive diagnostic screening for the detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by a qualified healthcare professional trained in its use.
    Device Description
    The NoTouch BreastScan consists of a group of hardware components. The hardware components consist of: - Two digital infrared cameras - . A computer system, with printer - . An air conditioner unit - . A specially designed mobile cart. Software Components include: - . NoTouch BreastScan Software - . PDF Viewer - . Drivers for Infrared imagers - . ThermaCam Researcher Software
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