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510(k) Data Aggregation

    K Number
    K212012
    Device Name
    Follicle Clarity
    Manufacturer
    Date Cleared
    2022-01-19

    (205 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cycle Clarity

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.
    Device Description
    Follicle Clarity is a cloud-based software application package (software as a medical device, SaMD). Follicle Clarity automatically calculates the number and size of hypoechoic structures in the received transvaginal ultrasound images and displays the data graphically and in tabular format in the Follicle Clarity application. Graphic displays include both measurements made by the clinician (as measured by the ultrasonographer) as well as those calculated by Follicle Clarity. Graphs can be adjusted for various views of the data. Ultrasound images received are also displayed within the Application to allow the user to verify the resolution, contrast and anatomic completeness. The user is able to enter patient information such as cycle day, estradiol level and progesterone level in the patient profile for tracking. The user also has the ability to add or delete measurements as they feel are appropriate.
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