Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033400
    Device Name
    SENO ADVANTAGE
    Manufacturer
    GE MEDICAL SYSTEMS W-400
    Date Cleared
    2003-12-04

    (41 days)

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

    GE MEDICAL SYSTEMS W-400

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
    Device Description
    The Seno Advantage Workstation is a multi-modality review workstation. It includes a color flat panel for the multi-modality image review and two specific B&W high resolution monitors for the mammographic images review. Moreover, a dedicated keypad is provided to increase productivity. The Seno Advantage is positioned to be the system of choice for all users of Modality: CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC. The Hardware configuration of Seno Advantage is the following: HP XW8000 Workstation, Monitors specifications (NEC Flat Panel 18.1" LCD, 2 Grayscale 5 Mpixels CRT), Seno Advantage supports the following image networking: Standard 10/100/1000 Base-T Ethernet Protocols supported: DICOM 3.0 Storage SCU/SCP and Query/Retrieve SCU/SCP, InSite, TCP/IP network layer, SdCNet supported to query/retrieve from AW 3.1 and AW 4.0.
    Ask a Question

    Page 1 of 1