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510(k) Data Aggregation

    K Number
    K033955
    Device Name
    RTIST
    Manufacturer
    MIRADA SOLUTIONS LTD.
    Date Cleared
    2004-03-17

    (86 days)

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

    MIRADA SOLUTIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware. The volume and linear measurement functions are intended for evaluation and quantification of turnor measurements, location/displacement study, analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of 'avoidance' structure(s) during critical evaluation. Typical users of this system are trained professionals, including but not limited to radiologists, clinicians and technicians. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.
    Device Description
    The RTist is a software application acting as a stand alone Picture Archiving and The relise is a betting (PACS). It may be marketed as the software only as well as packaged with a standard 'off the shelf' PC Hardware. It is in effect a 'plug in' publication to the Fusion 7D/ Miraview / Reveal - MVS software platform (reference K020546) but is effectively 'vendor' neutral and as such an enhancement to many other medical image/ data management systems. The comprehensive array of features provided by the software allows the medical professional to visualize, review, interpret, manipulate, render and distribute medical image data stored in DICOM format. The networking component of the product allows the exchange of medical image data with any other DICOM-compatible or FTPcompatible server over a standard TCP/IP network. The RTist receives images in DICOM format, which are then converted into volume data format using core software technology. The RTist viewer provides interactive orthogonal and multi-planar reformatting which enables the user to evaluate abnormality or malformation displayed in the image. The volume and linear measurement features provided by the software enable evaluation and quantification of region of interest volume, linear measurements and location/displacement. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of structure(s) during critical evaluation. RTist processes an array of medical images including anatomical images (e.g. CT and conventional MRI), and functional images (e.g. SPECT and PET). The RTist software incorporates standard visualization features to display the input DICOM data and the results of the registration operations.
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    K Number
    K020546
    Device Name
    FUSION 7D
    Manufacturer
    MIRADA SOLUTIONS LTD.
    Date Cleared
    2002-04-26

    (66 days)

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

    MIRADA SOLUTIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fusion7D registers pairs of anatomical and functional volumetric images (e.g. MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g. MRI-MRI, CT-CT and MRI-CT) as a means to ease the comparison of image volume data by the clinician. The result of the registration operation aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared visually. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.
    Device Description
    Fusion7D is a software program running on a PC platform, which brings into alignment (registers) pairs of images from different imaging modalities. Fusion7D also includes functionality to read, display, and save the original volumetric data and the results of the registration operation by means of a graphic user interface that includes visualization, file browsing and control of input and output as described in the following text.
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