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510(k) Data Aggregation

    K Number
    K222683
    Device Name
    Fibroid Mapping Reviewer Application (FMRA)
    Date Cleared
    2023-07-17

    (314 days)

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

    Nesa Medtech Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Fibroid Mapping Reviewer Application (FMRA) is intended to be used by physicians in the clinic or hospital to generate a 3-D model from ultrasound images of the uterus of women with uterine fibroids. The model represents clinically relevant dimensions, including the location and dimensions of the fibroid (maximum length, width and depth).
    Device Description
    Fibroid Mapping Reviewer Application (FMRA) is a software that allows the user to load an existing ultrasound data into the application for calibration, review, annotation and generation of a 3D rendered uterus model. It aids in the measurement of fibroid dimensions and mapping the location of fibroids in the uterus. The ultrasound data of the patient's uterus, exported from ultrasound equipment via storage media such as a USB drive, is loaded into the proposed software. The user marks the anatomical features of the uterus and the fibroid. The software post-processes the 2D volume ultrasound images of the uterus to obtain the mapping & measurement of fibroids which are represented in a 3D rendered uterus model. It allows the clinician to know the parameters of each fibroid (like fibroid size and location) by just selecting a fibroid in the model. The proposed device is intended to assist qualified physicians in accurate diagnosis and planning of image guided interventional of uterine fibroids.
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