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510(k) Data Aggregation

    K Number
    K131795
    Device Name
    NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
    Manufacturer
    ORFIT INDUSTRIES NV
    Date Cleared
    2013-09-26

    (100 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS

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

    The NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are used to retain and reproduce a patient's position during radiation therapy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification document from the FDA regarding "NANOR and EFFICAST/NANOR Hybrid Thermoplastic Materials". This document is an approval letter and an "Indications for Use" statement.

    It describes the device as thermoplastic materials used to retain and reproduce a patient's position during radiation therapy. It establishes the device's regulatory classification and that it is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth, or adjudication methods. Therefore, I cannot extract the requested information as it is not present in the provided text.

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