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510(k) Data Aggregation

    K Number
    K092125
    Device Name
    PRESIDIO PACS
    Date Cleared
    2009-12-10

    (148 days)

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

    REAONIX SECURITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Presidio PACS software is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physician, nurses, technicians and computer system professionals. To support the diagnostic interpretation of mammography studies, Presidio PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.
    Device Description
    The Presidio PACS include the following major components: Workstation, Enterprise and RIS. The Presidio PACS workstation is used to view, edit, manipulate, annotate, analyze, store and distribute images and data that are stored and managed in the Presidio PACS Enterprise for diagnosis. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data. All acquired image data is preserved in the format in which it is received. Changes may be made to the presentation of the images. These changes are saved as display definitions only and do not alter the acquired image pixel data. Any and all display definitions applied to an image can always be reversed to the acquired state. The Presidio PACS workstation may also be used in a remote location, away from the healthcare facility, as long as the workstation has the ability to connect, via network, to the primary healthcare facility where the Presidio PACS Enterprise is located. The Presidio PACS Workstation extends its diagnostic and productivity capabilities into the mammography reading environment and may also be used for the primary interpretation of digital mammography images with a FDA approve 5MP monitor. The Presidio PACS Workstation has a modular software architecture which allows adding addition feature or enhancements in the form of plug-ins without any modification to the existing software code base. Presidio PACS Enterprise software delivers a complete, scalable storage solution for diagnostic images. Images can be stored in uncompressed, lossless or lossy. The system also has the ability to send data to DICOM ready devices via the DICOM standard protocol. It is a DICOM compliant solution for image storage, retrieval and transmission. The Enterprise Archive provides redundancy in long-term storage in several ways, including Redundant Archives, Media Copy, and Application Service Provider (ASP) Archive. Presidio RIS provides a hospital or clinic with automated tools to electronically schedule and manages patient exam information. The Presidio RIS utilizes a Workstation client that provides referring physicians the added flexibility to instantly view and schedule their own patients' radiographic services. The Presidio PACS software application is a software only solution and will use 'off the shelf' PC and server hardware technology that meets defined minimum specifications.
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