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510(k) Data Aggregation
K Number
K100236Device Name
STAIR SYSTEMS PACS & DICOM VIEWER
Manufacturer
Date Cleared
2010-03-29
(62 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
STAIR SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stair Systems Constellation 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 STAIR System PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. STAIR System & 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 STAIR Systems Constellation Suite Software system should not be used for Diagnostic review of full-field digital mammograms.
Device Description
STAIR Constellation Suite is a collection of applications Coded in the Microsoft C# application language. A color scheme defined as a way to identify both highlighted or important information within the user interface and as a "not so grey" environment that could stand up to a user who was likely to work 10-12 hours a day in front of it. The layout and design of the layers of the UI evolved from the "old design" of having 3 separate computers. each with a single monitor copy of a single element of the system into a modern, multimonitor native design which incorporates large performance gains through the use of Microsoft's DirectX technologies.
The core of the Suite is the database, is an adaptive star relational design for Microsoft SQL Server 2008 Enterprise. The data server provides a dedicated, central place to provide disaster recovery servicing, and the large multi-terabyte storage required for PACS. Attaching to this are Northstar PACS clients, Cosmos Enterprise Managmenet Clients, Apex Servers, and Cascade Servers; all of which are STAIR produced software products.
The Northstar PACS client is intended to be a desktop replacement product, with the interface dominating the screen space on a workstation.computer. TThis design decision was made to accommodate non- technical doctors who, we found, typically prefer to have a simplified and unobtrusive environment to work in. Color based exam status listings were evolutionary, and grew from the initial 'field of green' into the more advanced dynamic tree view seen today in the client. It is a multi-monitor capable client, currently configurable in a 1, 2, or 3 monitor footprint.
Cosmos represents the nerve center of the STAIR Constellation Suite, providing services for securing the STAIR network, maintaining Paperless workflow, and other such critical day-today system maintenance tasks. Typically users will include hospital or practice administrators and functional personnel who may need to make modifications to STAIR database entries. It is an OLTP client, and requires port level access to the main STAIR database central server installation to function (we use DSN-less connections to the database usually requiring port 1433 to be excepted in the workstation's firewall rule set). The client performs many tasks, some of which are not relevant to every customer. though we encourage adoption of STAIR electronic processes by our clients in order to help them streamline their office efficiency. RIS integration is partially available (per vendor, STAIR offers no supported HL7 interface at this time), and can be incorporated in most cases to allow a RIS system to perform synchronization and workflow tasks in harmony with STAIR kept data records.
The Apex DICOM Storage Server provides the primary server capabilities of the STAIR system. It was built to be automatable such that it typically runs unattended, but a user interface is used to both help monitor and control the various DICOM storage processes necessary to import each study from an external source (modality, another PACS, etc). The Apex server incorporates a DICOM SCP service grouping that allows for DICOM ping response, client protocol negotiation, transfer syntax negotiation, and several other system-level DICOM negotiations. As each case is received; it is stored via a Service host to the local hard drive (into the STAIRIMAGE hierarchy), it is queued for storage at the top, and it is stored as data to the main database in one of 8 available simultaneous thread 'putaway' processes (shown as 'idle').
The STAIR Cascade is a DICOM SCU, and auxiliary compression Server product originally designed to allow the send and receive functions of DICOM to be split from the STAIR Apex product and balanced onto a separate physical server. This was to allow for load balancing within the STAIR Enterprise, and the product has evolved now into a secondary server role, handling transmission queues for all enterprise clients. To allow for DICOM transmissions to be seamless, we use a database table XMISSION QUES, and each client transmission request to the database are handled as a threaded process (8 simultaneous). Each process begins by downloading the Imageset for a requested case from the STAIR database to a local cache, where it is then added to a queue within the program for processing. As each queue slot opens, another case is promoted until the queue empties.
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