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510(k) Data Aggregation

    K Number
    K955811
    Device Name
    AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    1996-03-29

    (94 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The auxiliary patient table is designed to further accommodate large patients, trauma patients, claustrophobic patients, and those patients requiring monitoring. The new auxiliary table is designed to support up to 200kg (440 lbs) and is compatible with the commercially available CP Head and Multi-purpose Coils. This new system option is not intended as a transportation trolley.

    Device Description

    The auxiliary patient table docks into the standard OPEN table area and increases the vertical gap (ie. patient gap) of the magnet. The auxiliary patient table consists of a base frame, an extension frame, and a table plate.

    AI/ML Overview

    This Siemens 510(k) summary (K955811) describes an auxiliary patient table for the MAGNETOM OPEN MRI system. It does not contain information about a study with acceptance criteria and device performance as it's a submission for a device modification, not a new AI/software-based medical device.

    Therefore, I cannot provide the requested table or response for points 2-9 based on the provided text. The document focuses on showing that the auxiliary patient table does not change the fundamental safety and performance of the existing MRI system.

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