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510(k) Data Aggregation

    K Number
    K043350
    Device Name
    MISTAR, MODEL V3.2
    Manufacturer
    APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD.
    Date Cleared
    2004-12-15

    (9 days)

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

    APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical imaging network, and can receive digital images and data from various sources (including but not limited to CT, MR, NM, and PT). MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring. MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.
    Device Description
    MIStar is a software package, which runs on an Intel-based PC platform. It allows manipulation, visualization and processing of medical images acquired with various clinical scanners and stored in DICOM and for other proprietary formats. MIStar allows transfer of DICOM 3.0 images over a medical imaging network. MIStar also provides post-processing of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer. It allows visual inspection of time intensity curves and calculation of parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also allows calculation of various perfusion related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability) from dynamic CT data. The results are displayed in a user-friendly graphic format as parametric images that provide supplementary information for diagnosis purposes.
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