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510(k) Data Aggregation

    K Number
    K982769
    Device Name
    MITRA IMAGING INC. EXHIBIT
    Manufacturer
    MITRA IMAGING, INC.
    Date Cleared
    1998-11-03

    (88 days)

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

    MITRA IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Exhibit is a software package, which may be marketed as a software only solution, as well as in coniunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols. lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device. Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.
    Device Description
    Exhibit is a software package, which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols. lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device. Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.
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    K Number
    K974102
    Device Name
    MILTRA IMAGING INC., IMAGE VAULT
    Manufacturer
    MITRA IMAGING, INC.
    Date Cleared
    1998-01-20

    (81 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITRA IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vault is intended to act as a long term storage device (archive) for medical images. Vault is a networked device that acts as a DICOM Storage Service Class Provider (SCP): - Images can be sent to it via the DICOM protocol, from modalities or other devices that are sources of medical images. - Images can subsequently be queried and retrieved via the DICOM protocol, to imaging workstations and other processing devices. - Internally, Vault is optimized to provide secure storage for a very large number of images, and to provide rapid retrieval on demand. To that end, Vault includes high capacity storage media, and has implemented hierarchical storage management software to manage cache storage effectively.
    Device Description
    Image Vault is a software package which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Image Vault is a PC-based, DICOMcompliant PACS device that is able to send & receive, display, store, and archive DICOM non-compressed and JPEG-compressed images. Images can be archived using standard magnetic tapes. It also has the ability to read/write a collection of images to/from CD-R media in a method defined by DICOM. Images can be viewed using a simple display utility, for the purposes of properly identifying patients and their corresponding studies, and is not intended to be used for diagnosis. Image Vault uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Image Vault.
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    K Number
    K970652
    Device Name
    MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
    Manufacturer
    MITRA IMAGING, INC.
    Date Cleared
    1997-05-02

    (70 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITRA IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended user of this device is a DICOM software package that will enable any hospital PC with adequate radiographic monitor and enough memory to be utilized with Radiological image viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, . digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.
    Device Description
    The Film Express software is a DICOM software package that will enable any hospital PC with adequate radiographic monitor and enough memory to be utilized with Radiological image viewer. This uson as the Lumisys, Lumiscan film Quality scanners, such as the Lambyo, . digitizers, and other DICOM conformant devices such as CT scanners or clinical workstations.
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