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510(k) Data Aggregation

    K Number
    K033340
    Device Name
    LEKSELL SURGIPLAN WITH IMAGEMERGE
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2004-02-12

    (118 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LEKSELL SURGIPLAN WITH IMAGEMERGE

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

    The Leksell SurgiPlan® with ImageMerge™ accessory is a computer system intended for use in planning invasive intra-cranial stereotactic surgical procedures

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Leksell Elekta SurgiPlan, a stereotaxic instrument. It does not contain information on device acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to a legally marketed predicate device, but it doesn't detail performance studies or specific acceptance metrics.

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