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510(k) Data Aggregation

    K Number
    K113456
    Device Name
    READY VIEW
    Manufacturer
    GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
    Date Cleared
    2012-06-15

    (207 days)

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

    GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multiparametric analysis and may provide clinically relevant information for diagnosis.
    Device Description
    READY VIEW (K110573) is a suite of applications developed to improve multi-parametric exams by enobling the analysis of MR generated data sets containing multiple images for each scan location. The MR data sets may be any of the following: - A time series - A diffusion weighted scan - A diffusion tensor scan - A variable echo imaging - A blood oxygen level dependent imaging - Spectroscopy (Single voxel and 2D or 3D CSI) The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets. Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols: - FiberTrak - Arterial Spin Labeling (ASL) READY View along with Brain View option are available on the Advantage Workstation (AW), Advantage Workstation Server Gen 2 and AW Server PACS, for viewing and processing Magnetic Resonance images. The basis for this submission is a modification of a legally marketed device to incorporate additional features. The following additional functional protocols can now be post processed using READY View software: Brain View which is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of neurological and oncological diseases now offers two additional advanced protocols : - BrainStat - BrainStat AIF Body View is a post processing image analysis software package that provides advanced techniques to aid in the diagnosis of oncological diseases in the human body. Body View is an option : with the READY View platform and offers two advanced protocols: - Signal Enhancement Ratio (SER) - MR Standard READY View along with Brain View and Body View options are available on the Advantage Workstation (AW), Advantage Workstation Server Gen 2 and AW Server PACS, for viewing and processing Magnetic Resonance images.
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    K Number
    K110573
    Device Name
    READY VIEW
    Manufacturer
    GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
    Date Cleared
    2011-05-03

    (63 days)

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

    GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    READY View is an image analysis software that allows the user to process dynamic or functional volumetric data and to generate maps that display changes in image intensity over time, echo time, b-value (Diffusion imaging) and frequency (Spectroscopy). The combination of acquired images, reconstructed images, calculated parametric images, tissue segmentation, annotations and measurement performed by the clinician allows multi-parametric analysis and may provide clinically relevant information for diagnosis.
    Device Description
    READY View is a suite of applications developed to improve multiparametric exams by enabling the analysis of MR generated data sets containing multiple images for each scan location. The MR data sets may be any of the following: - A time series - A diffusion weighted scan - A diffusion tensor scan - A variable echo imaging - A blood oxygen level dependent imaging - Spectroscopy (Single voxel and 2D or 3D CSI) The READY View platform provides a combination of protocols, applications and tools that enables a fast, easy and quantified analysis of the multiple data sets. Brain View is a post processing image analysis software package that provides advanced techniques to aid in the diganosis of neurological and oncological diseases. Brain View is an option with the READY View platform and offers two advanced protocols: - FiberTrak - Arterial Spin Labeling (ASL) READY View along with Brain View option is available on the Advantage Workstation (AW) and Advantage Workstation Server Gen 2, for viewing and processing Magnetic Resonance images.
    Ask a Question

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