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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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
    AI/ML Overview

    The provided text is a 510(k) summary for the NoTouch BreastScan device. While it states that "Testing of NoTouch BreastScan was performed as per the requirements" and "Complete validation and verification was performed on all software and hardware subsystems," it does not contain the detailed acceptance criteria or the specific study results proving the device meets these criteria.

    The document primarily focuses on establishing substantial equivalence to a predicate device (BREASTSCAN IR) and outlining the general intended use and technological characteristics. There is no information regarding 1. acceptance criteria, 2. sample size for test set and data provenance, 3. number and qualifications of experts for ground truth, 4. adjudication method, 5. comparative effectiveness study (MRMC), 6. standalone performance, 7. type of ground truth used, 8. sample size for training set, or 9. how ground truth for the training set was established.

    Therefore, I cannot fulfill your request with the provided input because the necessary information about acceptance criteria and the detailed study results are absent.

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