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510(k) Data Aggregation

    K Number
    K072728

    Validate with FDA (Live)

    Device Name
    SYNGO MULTIMODALITY WORKPLACE
    Manufacturer
    SIEMENS AG, MEDICAL SOLUTIONS
    Date Cleared
    2008-04-22

    (209 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K061964
    Predicate For
    K092519,K123584,K131299
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The syngo MultiModality Workplace is intended to be used for viewing, manipulation, communication, and storage of medical images and data exchange media.

    The syngo MultiModality Workplace can be used as a stand-alone device or as with a variety of cleared and unmodified syngo- and Windows XP-based software options.

    The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.

    Device Description

    This premarket notification covers only the Siemens syngo MultiModality Workplace (sMMWP) (VE26A), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syngo MultiModality Workplace (sMMWP) (VE26A) offers a comprehensive solution to view, optimize process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information.

    Due to special customer requirements based in the modality image type and the clinical focus, the syngo MultiModality Workplace (sMMWP) (VE26A) can be offered with different combinations of cleared and unmodified clinical applications. syngo applications can be added to the MultiModality Workplace either individually or as clinically focused packages.

    AI/ML Overview

    The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. This 510(k) summary focuses on establishing substantial equivalence to a predicate device based on intended use and similar technological characteristics, rather than presenting a performance study with detailed acceptance criteria.

    Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document states: "Siemens is of the opinion that the syngo MultiModality Workplace (sMMWP) (VE26A) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device." This indicates that the primary method for demonstrating safety and effectiveness was through comparison to an already cleared device, not through a new performance study with defined acceptance criteria.

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