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510(k) Data Aggregation

    K Number
    K031999
    Device Name
    ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2003-07-25

    (28 days)

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

    ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT

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

    The Leksell Stereotactic System with MR post kit is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Elekta Leksell Stereotactic System, indicating that the device is substantially equivalent to a predicate device. It defines the indications for use but does not contain details of any performance studies, acceptance criteria, sample sizes, or ground truth establishment.

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