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510(k) Data Aggregation

    K Number
    K203195
    Device Name
    Simpleware ScanIP Medical
    Date Cleared
    2021-04-01

    (155 days)

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

    Synopsys (Northern Europe) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Simpleware ScanlP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
    Device Description
    Simpleware ScanIP Medical is image processing software that enables users to import, visualize, and segment medical images, and export digital 3D models. These models can be used in the software for pre-surgical tasks, and can also be used to produce output files suitable for additive manufacturing (3D printing). Simpleware ScanIP Medical also has functionality for transferring from and to third-party software packages. Simpleware ScanIP Medical is a modular product, including the following functionalities: - Import of medical images in various formats - Transferring files from and to computer-aided design (CAD) software packages - Image filtering and segmentation tools - 2D and 3D visualization of image data and CAD drawings - Analysis, measurements, and statistics from 3D image data and CAD drawings - Generating and exporting meshes to Finite Element (FE) packages. - Generating and exporting models to CAD software - Support for scripting in a number of programming languages
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