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510(k) Data Aggregation

    K Number
    K222938
    Device Name
    Ablation-fit
    Manufacturer
    R.A.W. Srl
    Date Cleared
    2023-09-12

    (351 days)

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

    R.A.W. Srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ablation-fit is a medical imaging application available for use with liver ablation procedures. Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement. Ablation-fit is used to assist physicians in confirming ablation zones during follow-up. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
    Device Description
    Ablation-fit is a stand-alone medical imaging software that integrates Reconstruction, Segmentation, Registration and Visualization algorithms into a user interface to support physicians during liver ablation treatments planning and follow-up. Ablation-fit allows to perform the entire workflow from DICOM (Digital Imaging and COmmunications in Medicine) images to 3D reconstruction of volume of interests, ablation probe placement and treatment outcome verification. Specifically, Ablation-fit main functionalities include: - Image loading from different supports (including PACS), - DICOM images handling and visualization in axial, sagittal, coronal views, - image segmentation, - tools for manual edit of segmentations. - 3D visualization, - virtualization of ablation probe placement, - pre- and post-treatment images registration. The software permits segmentation and 3D reconstruction of volumes of interest. The software contours all of this anatomic information not only in axial, sagittal, and coronal planes for 2D visualization, but also three-dimensionally. Every computed segmentation can be manually modified in the 2D axial visualization and consequently the three-dimensional mapping of the scan changes accordingly. Ablation-fit let the user simulate the virtual needle insertion and shows the desired ellipsoid of ablation. Once the ablation procedure has been performed, pre- and post-treatment scans are registered. Consequently, the software can verify whether the ablation zones entirely surrounds the lesion and the safety margin.
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