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510(k) Data Aggregation

    K Number
    K112460
    Device Name
    MULTIPLE
    Manufacturer
    LARSON MEDICAL PRODUCTS, INC.
    Date Cleared
    2011-10-07

    (42 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

    In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate accurate treatment of tumors.

    Patients are those that have been diagnosed and are undergoing treatment for cancerous tumors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for several medical devices, primarily baseplates and support systems used in radiation therapy. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval notice, not a scientific study report.

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