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510(k) Data Aggregation

    K Number
    K062488
    Device Name
    IQ-SYSTEM PACS SYSTEM
    Manufacturer
    IMAGE INFORMATION SYSTEMS, LTD.
    Date Cleared
    2006-09-19

    (25 days)

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

    IMAGE INFORMATION SYSTEMS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iQ-System PACS is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
    Device Description
    iQ-System PACS is a software device for network or web-based medical image viewing and manipulation, running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. iQ-System PACS fully supports the DICOM standard and has functionality for advanced DICOM viewing, Hanging Protocol, and 3D image processing (Orthogonal and Oblique Multiplanar Reconstructions (MPR), Maximum Intensity Projections (MIP), Surface Shaded Display (SSD), and Volume Rendering (VRT)). The main iQ-SYSTEM PACS modules are iQ-LITE, iQ-Print, iQ-View (including iQ-3D), and iQ-Web.
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