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510(k) Data Aggregation

    K Number
    K960613
    Device Name
    GE ADVANTAGE WINDOWS REVIEW WORKSTATION
    Manufacturer
    GE MEDICAL SYSTEMS
    Date Cleared
    1996-04-30

    (77 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K913770,K942120
    Why did this record match?
    Device Name :

    GE ADVANTAGE WINDOWS REVIEW WORKSTATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GF: Advantage Windows Review Workstation is a two dimensional review station which allows selection and review of DICOM images from Computed Tomography (CT), Magnetic Resonance (MR), X-Ray (XR), Computed Radiography (CR) and Secondary Capture (SC) modalities.

    Device Description

    The GE Advantage Windows Review Workstation consists of a Sun Microsystems Spare 4, 5, 20 or UltraSparc Unix workstation or equivalent with 32 to 128 MBytes of RAM, 1 to 4 GBytes of mass storage memory, an Ethernet or ATM networking interface and 1 to 4 color landscape or high resolution monochrome monitors. The GE Advantage Review Windows software application is designed and produced by GE Medical Systems. Earlier versions of this software were included in previous 510(k) Premarket Notification submissions (K913770, K942120).

    AI/ML Overview

    This document is a 510(k) summary for a GE Medical Systems device modification (K960613). It focuses on the GE Advantage Windows Review Workstation. Based on the provided text, the document describes a device modification and primarily discusses its substantial equivalence to previously cleared devices.

    Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the detailed study specifics requested in your prompt.

    The "Summary of Studies" section only states: "In addition to system design verification tests to assure conformance with the design specifications, the design has or will undergo further validation to assure overall user satisfaction." This indicates that design verification tests were done to meet specifications and that further validation for user satisfaction was planned or ongoing. It does not provide any detailed results or acceptance criteria relating to clinical performance.

    Therefore, I cannot populate the requested sections based on the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical or clinical study report.

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