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510(k) Data Aggregation

    K Number
    K142779
    Device Name
    SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED
    Manufacturer
    SIMPLEWARE LTD.
    Date Cleared
    2015-04-17

    (203 days)

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

    SIMPLEWARE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ScanIP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options. Scan1P is not intended to be used for mammography imaging.
    Device Description
    ScanIP represents a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner to an output file. ScanIP provides a core image processing interface with several additional modules available to users – these include +CAD, +FE and +NURBS - which provide further options for working with image data. +CAD enables the integration of computer-aided design (CAD) drawings such as implants with patient-specific data; +FE allows segmented image data to be exported as computational models for physics-based simulations in other software; +NURBS is designed to allow users to export segmented data as NURBS IGES files to CAD software. ScanIP is written in C++ and designed using the integrated development environment (IDE) Microsoft Visual Studio. Minimum hardware requirements for the operating system are Windows 7, Windows 8, Windows Vista, and Windows XP. 32 and 64 bit versions of the software are available. Minimum processor requirements are an Intel Core i3 or equivalent; minimum memory requirements for the software to run are 4096 MB (4GB), while an OpenGL compatible graphics card with 32 MB of RAM is required. The screen resolution of a workstation should be a minimum of 1024 x 768 high colour (16 bit), and 10 GB of disk space is recommended as a minimum. The software is required to be able to visualise and process medical images using a range of filters and tools, and can export models as output files. ScanIP meets DICOM standards for the transfer of medical images. The software is also intended for use in the early stages of pre-surgical planning for visualising patient-specific data, taking measurements and obtaining statistics (such as bone density, distances and angles between arteries), and for integrating computer drawings of implants with patient data to evaluate fitness for use. This functionality has applications to implant evaluation and export of models for simulation in other software. Output files can be used in these other applications; ScanIP does not integrate with them directly. Processed medical images can also be exported as output files to 3D printing processes for the creation of physical models that can be used in pre-surgical planning (inspection of implant fit), and as computational models to other software programs for running simulations (e.g. stress/strain limits in bone, fluid flow through vessels and airways). ScanIP has FDA clearance to generate 3D models and export these models in a format suitable for 3D printing to be used as physical models for visualization or educational purposes only. This clearance does not cover medical devices manufactured from those output files.
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