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510(k) Data Aggregation

    K Number
    K190575
    Device Name
    iBreastExam
    Manufacturer
    UE LifeSciences Inc.
    Date Cleared
    2019-07-16

    (132 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 Gen II 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 Gen II device is intended for use by a qualified healthcare professional trained in its use and is not for home use.
    Device Description
    iBreastExam Gen II is a visual mapping system, intended to produce a surface pressure map of the breast as an aid in documenting breast lesions identified during a clinical breast exam. The use of iBreastExam Gen II does not involve the use of any ionizing radiation. The iBreastExam Gen II system consists of a group of hardware and software components. The hardware component(s) consist of: iBreastExam Gen II Scanhead, Computer System, USB Wall Charger and Charging Cables. The software component(s) consist of: iBEConnect Software Program.
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