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510(k) Data Aggregation

    K Number
    K020995
    Device Name
    EFILM WORKSTATION WITH MODULES
    Manufacturer
    EFILM MEDICAL, INC.
    Date Cleared
    2002-04-12

    (15 days)

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

    EFILM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
    Device Description
    eFilm Workstation with Modules is one of the components of a PACS (Picture Archiving and Communications System). eFilm Workstation with Modules is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application image viewing and manipadian in are acquired and stored on an image server in DICOM and/or other proprietary formats. eFilm Workstation with Modules can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
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    K Number
    K013631
    Device Name
    EFILM VIDEO
    Manufacturer
    EFILM MEDICAL, INC.
    Date Cleared
    2001-11-20

    (15 days)

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

    EFILM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eFilm Video™ is a software application that captures video streams from analogue medical image acquisition devices with video outputs and converts these streams to DICOM compliant cine loops. These images can be sent to DICOM compliant devices for display and processing. Users may also input patient demographic information that is related to the captured images.
    Device Description
    eFilm Video™ is a software application that is used for capturing video streams from analogue medical image acquisition devices with video outputs and converting these streams to DICOM modiant cine loops. Users may capture single stills or consecutive images and save them as DICOM files that can be viewed and manipulated in a picture archiving and communications viewing application.
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    K Number
    K012211
    Device Name
    EFILM WORKSTATION
    Manufacturer
    EFILM MEDICAL, INC.
    Date Cleared
    2001-07-31

    (15 days)

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

    EFILM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
    Device Description
    eFilm™ Workstation is one of the components of a PACS (Picture Archiving and Communications System). eFilm™ Workstation is a software application that provides image viewing and System). Chim - Wonotion 10 a setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other modioal integor that an also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
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