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510(k) Data Aggregation

    K Number
    K973131
    Device Name
    SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    1997-11-12

    (83 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K953522,K970174,K970064
    Why did this record match?
    Device Name :

    SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)

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

    The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide lowend image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.

    The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.

    Device Description

    This premarket notification covers the SIENET gateway product line, specifically, SIENET MagicLink I (ISI-Gateway) and MagicWeb (web server).

    The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide low-end image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.

    The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.

    These products support industry standard information transmission and communication protocols.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

    The document is a 510(k) summary for the SIEMENS SIENET Gateway product line (MagicWeb and MagicLink I). It describes the device, its intended use (medical communication devices for image and report distribution, and data transfer), and claims substantial equivalence to previously marketed devices. The FDA letter confirms the substantial equivalence determination.

    Therefore, I cannot fulfill your request for the detailed study information.

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