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510(k) Data Aggregation

    K Number
    K231677
    Device Name
    EdgeFlow UH10
    Manufacturer
    Date Cleared
    2024-03-06

    (271 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Edgecare Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EdgeFlow UH10 is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively. It is intended for use in professional healthcare facilities, such as hospitals, clinics, by qualified and trained healthcare professionals. The EdgeFlow UH10 supports B-mode and harmonic imaging modes.
    Device Description
    This device is an ultrasound system that measures urinary bladder volume noninvasively using ultrasound. The system consists of a handheld unit (console) with a 3.2inch touchscreen display and a permanently attached probe. The system calculates the bladder volume based on ultrasound images using the probe. The images and the bladder volume are displayed on the screen. The results of the exam are automatically saved and saved exams are managed on the screen. Data can be exported to a standard PC using a wired USB export or Wi-Fi communications. The system includes a rechargeable lithium-ion battery can be charged in the system directly connecting a USB cable with a power adapter. Also, a cradle is available for charging the battery or printing the results. The deep learning model employed in EdgeFlow UH10 comprises three components: feature extraction, binary classification, and semantic segmentation networks. B-mode ultrasound images undergo classification in the network to determine the presence of the bladder, while the segmentation network is responsible for delineating the bladder area. Live B-mode ultrasound images are acquired once the scan button is pressed to start scanning. The output of the deep learning model manifests as the bladder contours displayed as green lines in the ultrasound images, and the bladder volume is subsequently calculated based on these lines when the scan button is pressed.
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