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510(k) Data Aggregation

    K Number
    K161601
    Device Name
    Dynamika
    Date Cleared
    2017-05-17

    (342 days)

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

    IMAGE ANALYSIS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dynamika Version 5.0 is an image processing software package to be used by trained medical professionals with a level of medical expertise (including physicians, radiology technicians). The software runs on a standard offthe-shelf workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Dynamika Version 5.0 provides both viewing and analysis capabilities of dynamic imaging datasets acquired with MRI. Dynamika Version 5.0 is used for the visualization, analysis and reporting of dynamic MRI data, showing the properties of changes in contrast over time. The package may be used to calculate permeability parameters related to the leakage of injected contrast material from intravascular to extracellular space. Parametric maps may be overlaid onto the original image for interpretation. Dynamika Version 5.0 is intended to be used within hospitals and medical clinics. It is licensed and not intended for general public use.
    Device Description
    Dynamika Version 5.0 is a software package for viewing, analysis and processing of medical images from MRI. The software is compliant with the DICOM standard and is suitable for running on Windows, Macintosh or Linux operating systems. Dynamika Version 5.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information. The software provides a range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. The main features of the software are: - 1. Image Loading and Saving. - 2. Image Viewing. - 3. Image Manipulation. - 4. Image Analysis. - 5. Imaging Processing and Generation of Parametric Maps. - Permeability Post-processing. 6. - 7. Reporting of User-Selected Findings and Assessment. - Communication and Storage of Results (DICOM import/export, 8. query/retrieve and study storage). Dynamika Version 5.0 is designed for medical imaging professionals with expertise in interpreting medical MRI images. Dynamika Version 5.0 can also be used to view multi-modality, digital images including ultrasound and mammography images. However, the software package is not intended for primary interpretation of digital mammography images.
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