Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242647
    Device Name
    MySegmenter (v2.0.0)
    Manufacturer
    MySegmenter Technologies Inc.
    Date Cleared
    2025-04-16

    (225 days)

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

    MySegmenter Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room. The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications.
    Device Description
    MySegmenter (v2.0.0) is a software platform for visualizing medical images in 3D mesh format. processes images by analyzing the luminance of individual pixels to segment and highlight the regions of interest (specific anatomical areas). MySegmenter supports editing, modification and manipulation of segmented areas using various segmentation tools. The software features include: - Importing medical images in DICOM and other formats. - Viewing and navigating through DICOM images. - Segmenting selected regions using generic tools (segments, island effects, Boolean operations, etc.) - Editing segments with multiple slice edits, fast marching, watershed effects, etc. - Generating editable 3D STL files for different applications. - Converting the segment to mesh models. - Exporting the segmented models in STL format suitable for further manipulation and manufacturing.
    Ask a Question

    Page 1 of 1