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510(k) Data Aggregation

    K Number
    K112008
    Device Name
    TOUCHPACS SUITE
    Date Cleared
    2012-01-06

    (177 days)

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

    TOUCH MEDICAL SOLUTIONS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TouchPACS Suite software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non- DICOM information and data management system. The TouchPACS Suite PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shell" personal computers, business computers, and servers running standard operating systems. TouchPACS TouchMGR Suite DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from any OEM modality which support DICOM standard imaging data. The system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements. The TouchPACS Suite software is not for mammographic use.
    Device Description
    The TMS TouchPACS Suite is a collection of software applications coded in the Microsoft C# application language, using the Windows Presentation Foundation (WPF) libraries for user interface, that run on "off-the-shelf" Microsoft Windows-based personal or business computers to provide diagnostic imaging workstation capabilities. The system is designed to provide an environment for radiological diagnosticians which is "easy on the eyes"; so that the user can use the system for 10-12 hours per day without undue strain. The core of the system is the database, which is a relational design, using Microsoft SQL Server 2008 Enterprise edition as the Relational Database Management System (RDBMS). The database server provides a dedicated, central place to provide disaster recovery servicing (via standard SQL Server replication), as well as the large multiterabyte storage required for a PACS system. Attached to the RDBMS are TouchPACS client workstations, TouchMGR client workstations, and servers required for system operations: TMS DICOM SCP Server and Microsoft SQL Server. All of the aforementioned software modules, except for Microsoft SQL Server, are TMS software products. The TouchPACS Suite PACS client workstation is intended to be a desktop computer replacement product, with the interface dominating the screen space on a workstation computer. The TouchMGR client workstation represents the nerve center of the TouchPACS Suite, providing services for securing the TMS network, maintaining users, allowing paperless workflow, and other such critical day-to-day system maintenance tasks. The TMS DICOM SCP Server provides multi-threaded DICOM v3 server capabilities of the TouchPACS system.
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