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510(k) Data Aggregation

    K Number
    K061449
    Device Name
    SYNGO EXPERT-1
    Manufacturer
    SIEMENS MEDICAL SOLUTION
    Date Cleared
    2006-07-25

    (61 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K052423
    Why did this record match?
    Device Name :

    SYNGO EXPERT-1

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

    The syngo Expert-I option for all Siemens CT systems is intended to allow a remote access to the syngo CT workplace from clients inside the local area network.

    Device Description

    The syngo Expert-I option allows the local user of the syngo CT workplace to get help and assistance from other personnel on the local area network (LAN) to perform an evaluation of images faster and more efficiently. For this purpose, a remote user within the LAN can log on to the syngo CT workplace.

    AI/ML Overview

    The provided document is a 510(k) summary for syngo Expert-I. It primarily describes a remote access software for CT systems and confirms its substantial equivalence to a previously cleared device. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

    Therefore, I cannot provide the requested information. The document focuses on administrative and regulatory aspects rather than detailed technical validation of a device's performance.

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