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510(k) Data Aggregation

    K Number
    K053455
    Device Name
    ENCOMPASS.NET
    Manufacturer
    EMPIRIC SYSTEMS, LLC
    Date Cleared
    2006-01-25

    (47 days)

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

    EMPIRIC SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
    Device Description
    Encompass.Net™ is a fully web-based system that operates in a Microsoft Internet Explorer (Version 6.0 and above) environment. Encompass.Net™ is run in a Windows 2003 environment, using Microsoft's Internet Information Server functions. The core database is Microsoft SQL 2000. Encompass. Net is intended to acquire medical images for storage, archiving, and routing to medical professionals. In addition, Encompass.Net allows medical professionals to retrieve medical images on demand using Internet communication protocols according to various user options and lossy and/or lossless compression techniques for subsequent review. A host of image process tools are available for the medical professional. In addition to Encompass. Net, the fully integrated RIS/PACS device, there are also multiple stand-alone PACS models (subsets of Encompass Net) that will be marketed. Those configurations are: R1.Net, R2.Net, and R3.Net.
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