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510(k) Data Aggregation

    K Number
    K163281
    Device Name
    FastStroke
    Manufacturer
    GEf Medical Systems SCS
    Date Cleared
    2017-01-26

    (66 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GEf Medical Systems SCS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement. The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
    Device Description
    FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement. The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients. FastStroke device has been tested with DICOM images from Discovery CT750 HD and Revolution CT using multi-phase CT Angiography. FastStroke is based on DICOM image based processing and would apply to any CT device that is able to acquire data in an equivalent multi-phase CT angiography (pursuant to the timing protocols in the user quide) manner. FastStroke is also made available as a standalone post processing application on the AW VolumeShare workstation (K110834) and AW Server platform (K081985) that host advanced image processing applications.
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