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510(k) Data Aggregation

    K Number
    K040443
    Device Name
    DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I
    Manufacturer
    DOME IMAGING SYSTEMS, INC.
    Date Cleared
    2004-06-16

    (117 days)

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

    DOME IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ is intended to be displaying and viewing radiographs of the breast for review and analysis by trained medical practitioners.
    Device Description
    The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ is a flat panel hi-resolution LCD monitor system for displaying gray scale medical images for diagnostic and referral use. The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower The Displays use active maths liquit aryonal and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly displays - The Dioplay controller via a Digital Visual Interface (DVI) 1.0 interface. to a common graphios arepray stors (TFTs) control transmissive liquid-crystal elements and use integrated Cold Cathode Fluorescent Tube (CCFT) backlight systems The and use miegrated Cold Cathodo Flabroom 7 Section 1 Section of 2018 DOME CSI uisplays five megapixolo of cattle LCD display panel, integrated drive x 2500 o-bit pixers. The system mora an external power supply. Optional connections to electronics, megrated backlight, and an oxlority, including keyboard, mouse, and calibration technology.
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    K Number
    K983815
    Device Name
    PACSCACHE
    Manufacturer
    DOME IMAGING SYSTEMS, INC.
    Date Cleared
    1999-01-14

    (78 days)

    Product Code
    LLZ, 90L
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOME IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PACScache is an integrated client server software system designed to allow rapid access to radiographic data (specifically high resolution images) through out the radiology department as well as the entire hospital or clinical setting. The product is intended to enable review of images through clinical information systems and allow review of images on a digital picture archiving and communication system (PACS) network using a personal computer or workstation configured for standard internet access.
    Device Description
    PACScache is an imaging software program used to view medical images on a personal computer. The software is designed to function with off-the-shelf hardware and software products including standard communications products. Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the scanner.
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