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510(k) Data Aggregation

    K Number
    K961739
    Device Name
    KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT
    Manufacturer
    KODAK HEALTH IMAGING SYSTEMS, INC.
    Date Cleared
    1996-11-14

    (195 days)

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

    KODAK HEALTH IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS). The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.
    Device Description
    The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.
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    K Number
    K961740
    Device Name
    KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT
    Manufacturer
    KODAK HEALTH IMAGING SYSTEMS, INC.
    Date Cleared
    1996-11-14

    (195 days)

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

    KODAK HEALTH IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS). The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.
    Device Description
    The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.
    Ask a Question
    K Number
    K961768
    Device Name
    KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
    Manufacturer
    KODAK HEALTH IMAGING SYSTEMS, INC.
    Date Cleared
    1996-08-22

    (106 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    KODAK HEALTH IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).
    Device Description
    Kodak's Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).
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    K Number
    K960981
    Device Name
    KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
    Manufacturer
    KODAK HEALTH IMAGING SYSTEMS, INC.
    Date Cleared
    1996-06-07

    (88 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    KODAK HEALTH IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching algorithm to facilitate fast access to previous imagery.
    Device Description
    The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5 or 20) with pre-installed propriatary software, 2) the magnetic BI ARCORACIP S OF 201 orage Array RAID subsystem), and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox. The RAID subsystem and the CD jukebox are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply Provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz.
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