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510(k) Data Aggregation

    K Number
    K151212
    Device Name
    Ziostation2
    Manufacturer
    QI IMAGING, LLC
    Date Cleared
    2015-11-04

    (182 days)

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

    QI IMAGING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ziostation2 is an image processing application software available for installation onto customer owned hardware. This application software can be networked to provide for sharing of resources. This application software receives medical images from modalities (mage scanning devices such as CT) or image archives such as PACS through network or media and provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. This application software is intended for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which Ziostation2 is being offered. Note: The clinician retains the ultimate responsibility for making the proper diagnosis based on standard radiological practices and visual comparison of the separate, unprocessed images. Ziostation2 is a tool to be used in support of those standard practices and visual comparisons.
    Device Description
    ZIOSTATION2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray X-ray Angiography, PET, SPECT, NM, SC, Mammography, X-ray Radiofluoroscopic image, RT Image.
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    K Number
    K130552
    Device Name
    CT PULMONARY ANALYSIS
    Manufacturer
    QI IMAGING, LLC
    Date Cleared
    2014-01-13

    (315 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    QI IMAGING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indications: The CT PULMONARY ANALYSIS software option is an independent image analysis software tool providing additional image process capabilities to the Ziostation system. The CT PULMONARY ANALYSIS option is intended to assist the physician in assessing possible airway obstruction.
    Device Description
    CT PULMONARY ANALYSIS is an optional software package designed to be used with the basic Ziostation DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The added capabilities provided by this additional software option for use with CT DICOM compliant images are: - Segmentation of lung and bronchial airway - Contour detection of airway walls - Evaluation of bronchial dimensions - Observation of cross-sectional image and variance of diameter/thickness/area of airway wall along airway - Integrated 3D visualization with MPR or A/C/S slice/slab viewing - Low Attenuation Analysis by Lung Sections
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