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510(k) Data Aggregation

    K Number
    K152716
    Device Name
    EV Insite System
    Manufacturer
    Date Cleared
    2016-03-24

    (185 days)

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

    PSP Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EV Insite System by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
    Device Description
    The EV Insite System is comprised of two pieces of software: EV Insite R and EXtServer. It is a medical image display and processing software product that provides users with capabilities relating to the storage, communication, digital processing and display within the system or across computer networks of medical images. Images can be searched and displayed in a number of layouts as well as stacked. Image and information processing functions include: paging, magnification, gradation, annotation, PET/CT fusion, multiplaner reconstruction (MPR), Maximum Intensity Projection (MIP), superimposing, measurement, multi-display, flip, rotate, and mirror, cine window level adjustment, and comparison display. The EV Insite system includes features to access and manage medical imaging studies from DICOM 3.0 compliant imaging modalities, and provides information after processing for diagnosis. The EV Insite System software displays image processing results and allows online image search and reading. It does not perform any automatic diagnosis. The system does not produce any original medical images but can be used for primary diagnosis, except for lossy compressed mammographic images which must not be reviewed for primary image interpretations unless using an FDA cleared display. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. All images located on the EV Insite system have been received from DICOM compliant modalities and/or image acquisition systems. The EV Insite system allows trained professionals to display and manipulate images stored in DICOM archive devices. These trained professionals include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants. The EV Insite system is designed to be deployed over conventional networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.
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