Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980243
    Device Name
    PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
    Manufacturer
    PARAMETER DEVELOPMENTS, INC.
    Date Cleared
    1998-04-03

    (70 days)

    Product Code
    LMB
    Regulation Number
    892.2010
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARAMETER DEVELOPMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DICOM Archival Server (DAS)/DICOM IntraNET Service (DIS), software product, provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical film-based processes.
    Device Description
    The DICOM Archival Server (DAS) software product provides for the centralized management and storage of radiographic studies, replacing or augmenting the historical filmbased processes. The operating system utilizes Microsoft @ Windows NT @ Release 4.0 and later. This environment provides for all communication (i.e. TCP/IP), file storage (e.g. NTFS), security management, and display management processes. It also insulates the DAS from detail hardware management processes, allowing customers to make whatever choices in these areas best serve them. This environment supports a variety of back-up/restore processes which may be used at the customer's discretion. The Microsoft© SQL Server product is used as the primary management component for the archive contents and for responding to requests. whether they be in the form of SQL Server direct requests or via the DICOM Query/Retrieve process. This software-only product is fully DICOM-3.0 compliant for the following DICOM Service Classes: Verification (SCP), Storage (SCP and SCU), Query/Retrieve (SCP), Print (SCU), Patient Management (SCU), Study Management (SCU), Results Management (SCU). This product consists only of software and executes in a Windows© NT© environment on Intel© platforms. This product, when combined with appropriate server platform hardware and operating system, falls into the FDA proposed designation of a PACS system as Class II (Special Controls). The following attributes are noted: this product accepts, stores and transfers images; no image processing is done by this product; no compressed images are accepted for storage by this product; this product will supply compressed images as requested by client products, at the level of compression requested by those clients; no image viewing is provided by this product; the reliability of the product is dependent upon the hardware on which the software is installed, and is determined by the installation; disaster recovery attributes of an installation are dependent upon installationdetermined policies, and are totally under the control of the installation. The DAS product contains the following advanced features to facilitate rapid movement of images to desired targets within a PACS system: automatic image forwarding and automatic image printing. Automatic image forwarding enables a policy-managed forwarding process wherein each image received by the DAS will automatically be forwarded to one or more target workstations based upon the following image contents: modality station name, body part, referring physician, and modality type. Automatic image printing is an extension of the automatic forwarding process wherein the forwarding target is a DICOM Print Service Class Provider. The DICOM IntraNET Service (DIS) software product provides for centralized distribution of stored radiographic studies. DIS is an integrated client-server software system designed to allow secured access to radiographic images by licensed medical professionals. The software's server and client ends rely on off-the-shelf Windows NT software with compatible Intel hardware. The client end accesses images through a WEB Browser similar to Microsoft's Internet Explorer through a Query/Retrieve process. The DIS system becomes an extended Viewer attached to a secured internal network or an extended secured Intranet using TCP/IP communications protocol. Full resolution, lossless images are always available to the Client Browser. If lossy compression where used, similar to our equivalent products listed in item 10; Kodak, Base-Ten, or Autocyt, we would recommend that they be used for secondary viewing only and not for diagnostic interpretation. This DIS software is intended to provide the means for medical professionals to display data generated by medical scanning devices on a personal computer or workstation. Competent healthcare professionals would reasonably be expected to exercise judgment in use of this information.
    Ask a Question

    Page 1 of 1