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510(k) Data Aggregation

    K Number
    K041581
    Device Name
    COMPACS, VERSION 1.0
    Manufacturer
    INTELLIGENT IMAGES SRL
    Date Cleared
    2004-06-22

    (8 days)

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

    INTELLIGENT IMAGES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, viewing, printing, processing, analyzing, reporting and communicating medical digital studies such as cardiac catheterization, echocardiography or general radiological studies.
    Device Description
    ComPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, archiving, viewing, processing, analyzing, reporting and communicating medical digital studies such as cardiac cathetetization, echocardiography or general radiological studies. ComPACS is a modular software device composed of different software modules operating in synergy and each responsible of different functions. The modules can be distinguished into general review station components, analysis components, reporting components, server components and gateway components. General Review Station Components: CornPACS viewer constitutes the basic module for a review station providing viewing capabilities and retrieving capabilities from DICOM files in removable media. ComPACS Archive introduces archiving and retrieving of studies on the local review station. ComPACS Net Client allows a review station to archive and retrieve studies from a ComPACS Net Archive or from a third party DICOM compliant PACS. ComPACS Multi-Media extends ComPACS Archive to import and archive multi-media files with conversion to the DICOM format. ComPACS audio introduces digital audio management capabilities. Analysis Components: The review station can be extended with different analysis modules. ComPACS QCA and ComPACS LVA provide respectively quantitative coronary analysis and left ventricular analysis on angiographic images. ComPACS Echocardiac, ComPACS Stress Echo provide different echo analysis features. ComPACS IVUS allows measurements and longitudinal image reconstruction on IVUS images. Reporting Components: ComPACS Reporting allows report creation and management. This component can be further subdivided into subcomponents in relation to the different type of reports: Generic, Echocardiac, angiographic, etc. ComPACS Dictation extends the reporting module to allow for audio dictation into the report. Server Components: ComPACS Net Archive is the basic server modules allowing and retrieving of studies from remote workstations equipped with a ComPACS Net Client module. ComPACS Security introduces user activity logging and user rights profiles management. ComPACS Storage Server provides DICOM network storage services as SCP. ComPACS Dictation Server manages the dictated reports and transfers them to an external transcription service. ComPACS Small Business Server and ComPACS Enterprise Server provide DICOM network services for small and large size networks respectively. Gateway Components: ComPACS Recorder is a device capable of digitizing analog video signals and converting to DICOM compliant files for storage on media or network transfer to a DICOM server.
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    K Number
    K022940
    Device Name
    IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
    Manufacturer
    INTELLIGENT IMAGES SRL
    Date Cleared
    2002-10-11

    (37 days)

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

    INTELLIGENT IMAGES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive. In-Vision View with Measurements Module supports JOMED DICOM files only. The software will not read DICOM images or loops stored using any other manufacturers' system.
    Device Description
    In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive. In-Vision View with Measurements Module provides an effective solution for physicians and interventional labs to review JOMED's In-Vision Gold digital IVUS DICOM video loops on a desktop PC or notebook. In addition, video loops and still frames can be exported to PowerPoint presentations for conferences, in-hospital training and lectures.
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