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510(k) Data Aggregation

    K Number
    K083018
    Device Name
    CENTRICITY PACS WEB DIAGNOSTIC
    Manufacturer
    GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
    Date Cleared
    2008-11-14

    (36 days)

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

    GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Centricity PACS Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicallyd, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed matther mages and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using and TDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed argepted by FDA. Typical users of this system are trained professionals, including but not the physicians, radiologists, nurses, medical technicians, and assistants.
    Device Description
    Centricity PACS Web Diagnostic (Web DX) PACS System is an Internet bases software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS Web Diagnostic (Web DX) PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentiumbased) and operating systems (Microsoft Windows 2000, Windows 98). The system does not produce any original medical images. All images located on Centricity PACS Web Diagnostic (Web DX) PACS System have been received from DICOM compliant modalities and/or systems.
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    K Number
    K082318
    Device Name
    CENTRICITY PACS IW
    Manufacturer
    GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
    Date Cleared
    2008-08-25

    (12 days)

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

    GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Centricity PACS IW ™ by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    Centricity PACS IW ™ PACS System is an Internet bases software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on Centricity PACS IW ™ PACS System have been received from DICOM compliant modalities and/or systems.
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