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510(k) Data Aggregation

    K Number
    K061018
    Device Name
    PLANAR DOME EX LINE MODEL DOME E2C
    Manufacturer
    PLANAR SYSTEMS, INC.
    Date Cleared
    2006-04-28

    (15 days)

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

    PLANAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planar Dome® EX line Model Dome® E2c is intended to be used in displaying and viewing digital medical images for review, analysis, and diagnosis by trained medical practitioners. This device must not be used in primary image diagnosis in mammography.
    Device Description
    The Planar Dome® EX line Model Dome® E2c is a flat panel hi-resolution AMLCD monitor system for displaying medical images. The system consists of an AMLCD monitor and a high-resolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images. CXtra is user-friendly software, the purpose of which is to optimize the display for DICOM-compliant viewing.
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    K Number
    K060136
    Device Name
    PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR
    Manufacturer
    PLANAR SYSTEMS, INC.
    Date Cleared
    2006-01-31

    (12 days)

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

    PLANAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planar DOME DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model E4c™ is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. This device must not be used in primary image diagnosis in mammography.
    Device Description
    The Planar DOME EX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models E4c Color™ is a flat panel hi-resolution LCD monitor systems for displaying medical images. The system consists of a LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images. Cxtra is user-friendly software that purpose is to optimize the display for DICOM-compliant viewing.
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    K Number
    K032638
    Device Name
    DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY
    Manufacturer
    PLANAR SYSTEMS, INC.
    Date Cleared
    2003-09-11

    (15 days)

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

    PLANAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
    Device Description
    The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are flat panel hi-resolution LCD monitor systems for displaying medical images. The system consists of a LCD monitor and a highresolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
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    K Number
    K032202
    Device Name
    DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
    Manufacturer
    PLANAR SYSTEMS, INC.
    Date Cleared
    2003-08-01

    (14 days)

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

    PLANAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
    Device Description
    The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are flat panel hi-resolution LCD monitor systems for displaying gray scale medical images for diagnostic and referral use. The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower electro-magnetic emissions and heat, and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly to a common graphics display controller via a Digital Visual Interface (DVI) 1.0 interface. The Displays' Thin Film Transistors (TFTs) control transmissive liquid-crystal elements and use intedrated Cold Cathode Fluorescent Tube (CCFT) backlight systems. The DOME C2 displays two megapixels of data in a portrait or landscape orientation of 1200 x 1600 8-bit pixels. The DOME C5i displays five megapixels of data in a portrait or landscape orientation of 2048 x 2560 8-bit pixels. Both display systems include the LCD display panel, integrated drive electronics, integrated backlight, and an external power supply. Optional connections to USB can provide enhanced system functionality, including kevboard, mouse, and calibration technology.
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