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510(k) Data Aggregation

    K Number
    K081109
    Device Name
    CORONIS 5MP MAMMO SL, MODEL MDMG 6121
    Manufacturer
    BARCOVIEW, MEDICAL IMAGING SYSTEMS
    Date Cleared
    2008-05-02

    (14 days)

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

    BARCOVIEW, MEDICAL IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coronis 5MP Mammo SL (MDMG 6121) Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
    Device Description
    Not Found
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    K Number
    K073007
    Device Name
    CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
    Manufacturer
    BARCOVIEW, MEDICAL IMAGING SYSTEMS
    Date Cleared
    2008-02-14

    (113 days)

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

    BARCOVIEW, MEDICAL IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K072875
    Device Name
    NIO 5MP DISPLAY, MODEL E5620
    Manufacturer
    BARCOVIEW, MEDICAL IMAGING SYSTEMS
    Date Cleared
    2008-01-22

    (105 days)

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

    BARCOVIEW, MEDICAL IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K073205
    Device Name
    NIO 5MP, MODEL MDNG-5121
    Manufacturer
    BARCOVIEW, MEDICAL IMAGING SYSTEMS
    Date Cleared
    2007-12-19

    (36 days)

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

    BARCOVIEW, MEDICAL IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070831
    Device Name
    VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
    Manufacturer
    BARCOVIEW MIS EDINBURGH
    Date Cleared
    2007-05-22

    (57 days)

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

    BARCOVIEW MIS EDINBURGH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.
    Device Description
    The Voxar 3D product family provides several levels of functionality: - Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions . (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution. - Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data. . endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vascular and other tubular structures and boundary detection. - Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows. custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Specialized clinical applications include: - Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other o lesions using tomographic Colonography), - Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts) - Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary o arteries to evaluate occlusive and aneurismal disease), - Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart), O - PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT o scanners)
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    K Number
    K070726
    Device Name
    NIO COLOR 3MP AND MDNC 3120
    Manufacturer
    BARCOVIEW, MEDICAL IMAGING SYSTEMS
    Date Cleared
    2007-05-02

    (48 days)

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

    BARCOVIEW, MEDICAL IMAGING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDNC 3120 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately. The Nio Color 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.
    Device Description
    MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing. Nio Color 3MP is a display system for medical viewing. It consists of 3 components: MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100). The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
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    K Number
    K062621
    Device Name
    NIO 5MP-21 AND MDNG-5121 CB
    Manufacturer
    BARCOVIEW
    Date Cleared
    2007-03-19

    (195 days)

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

    BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nio 5MP-21″ is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board BarcoMed Nio, will be marketed as separate device.
    Device Description
    Nio 5MP-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 CB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
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    K Number
    K062905
    Device Name
    NIO FUSION 4MP; MDNC 4130
    Manufacturer
    BARCOVIEW
    Date Cleared
    2006-12-29

    (93 days)

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

    BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nio Fusion 4MP is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Fusion 4MP, containing the display MDNC 4130, the software MediCal QAWeb and the graphic board MXRT 2100, will be marketed as separate device. "The MDNC 4130 is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 4130, which is part of the Nio Fusion 4MP system, will be marketed separately.
    Device Description
    MDNC 4130 is a 30" color LCD display for medical viewing. It is combined with MediCal QAWeb, a user-friendly software that allows to optimize the display for DICOM-compliant viewing. Nio Fusion 4MP is a display system for medical viewing. It consists of 3 components: MDNC 4130 is a 30" color LCD display. MXRT 2100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb is a softcopy OA software application for local calibration and QA control.
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    K Number
    K062131
    Device Name
    NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB
    Manufacturer
    BARCOVIEW
    Date Cleared
    2006-11-17

    (114 days)

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

    BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nio 5MP-M-21″ is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners. The MDNG-5121 BB is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.
    Device Description
    Nio 5MP-M-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 BB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards. The device consists of three components: One 5-megapixel flat panel display (MDNG-5121 BB). One 10-bit display controller (BarcoMed Nio board). NioWatch software. The flat panel display has a resolution of 2560x2048 pixels. It can be used in landscape and portrait mode. The BarcoMed Nio display controller board is an ultra-high speed board with a 8-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray. The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display and display controller information.
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    K Number
    K061924
    Device Name
    CORONIS 3MP AND MDCG 3120-CB
    Manufacturer
    BARCOVIEW
    Date Cleared
    2006-09-05

    (60 days)

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

    BARCOVIEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coronis 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be need in primary image diagnosis in mammography.
    Device Description
    Coronis 3MP is a display system for medical viewing. It consists of 3 components: MDCG 3120-CB is a 20.8" grayscale LCD display. MXRT 5100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent for a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
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