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510(k) Data Aggregation

    K Number
    K151207
    Device Name
    Proton Immobilization Solution
    Manufacturer
    ORFIT INDUSTRIES NV
    Date Cleared
    2015-07-28

    (83 days)

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

    Proton Immobilization Solution

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

    The Proton IMMOBILIZATION Solution is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment including electron, photon, and proton treatments.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the "Proton Immobilization Solution" device. It does not contain any information regarding acceptance criteria, device performance, study details, or ground truth establishment.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. The "Indications for Use" section (page 2) describes the intended purpose of the device but does not include any performance metrics or study results.

    Therefore, I cannot provide the requested information based on the provided text.

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