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510(k) Data Aggregation

    K Number
    K173444
    Device Name
    Quantitative Total Extensible Imaging (QTxI)
    Date Cleared
    2018-07-23

    (259 days)

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

    AIQ Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Quantitative Total Extensible Imaging (QTxI) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0. QTxI assists in the following indications: - Receive, store, retrieve, display and process digital medical images. - Create, display and print reports from those images. - Provide medical professionals with the ability to display, register, and fuse medical images. - Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans. - Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs.
    Device Description
    Quantitative Total Extensible Imaging (QTxl) is a software tool designed for use in medical imaging. It is stand-alone software which operates on Windows 7 and Windows 10. Its intended function and use is to provide medical professionals with the means to display, register and fuse medical images from multiple modalities including DICOM PET and CT. Additionally, it identifies Regions of Interest (ROIs) and performs ROI contouring allowing quantitative/statistical analysis of full or partial-body scans through registration to template space. QTxl is designed to support multiple image analysis modules. Each module is designed for a specific image analysis purpose. Currently QTxl includes only the Quantitative Total Bone Imaging (QTBI) module, which is designed to identify and measure hot-spots on PET scans. QTBI aids the efficiency of medical professionals through automatic quantification of ROIs and changes in those ROIs, including 3D interactive rendering of the patient skeleton with highlighted Regions of Interest. QTxI also functions as a Picture Archive and Communications System (PACS) intended to receive, store, retrieve, display and process digital medical images, as well as create, display and print reports from those images. It also provides platform features for security, workflow and integration.
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