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510(k) Data Aggregation

    K Number
    K962927
    Device Name
    IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    1996-09-25

    (58 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K962927
    Why did this record match?
    Device Name :

    IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS

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

    The new In-Room MRC is intended to facilitate conventional procedures. The new operating console allows the system operator to control and monitor main system functions inside the RF-cabin.

    Device Description

    The In-Room MRC consists of a local monitor and mouse. The local monitor is a liquid crystal display (LCD) with the same image resolution as the standard diagnostic console. The scan-room-mouse is positioned alongside the magnet and controls the functions of the local monitor. It is similar to the conventional track ball-mouse used at the standard MR console and is fully compatible with the software.

    AI/ML Overview

    This device is a Magnetic Resonance Diagnostic Device. It does not appear to use AI. The acceptance criteria and study information is not applicable for this device.

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