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510(k) Data Aggregation

    K Number
    K061540
    Device Name
    LEKSELL GAMMAPLAN
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2006-07-05

    (30 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K051022,K973441
    Why did this record match?
    Reference Devices :

    K051022, K973441

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

    Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.

    Device Description

    Leksell GammaPlan® is a computer-based dose planning system specifically designed for Eeksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for alse with the Losiments, in stereotactic radiosurgery and stereotactic radiotherapy.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary and approval letter, which primarily focuses on substantial equivalence to predicate devices and regulatory classification. It does not detail specific performance studies, acceptance criteria, or the methodology used to validate the device's performance.

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