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510(k) Data Aggregation

    K Number
    K223465
    Device Name
    RadianceTx Radionuclide Brachytherapy Source
    Manufacturer
    Radiance Therapeutics Inc.
    Date Cleared
    2023-01-11

    (55 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RadianceTx Radionuclide Brachytherapy Source

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

    The RadianceTx Radionuclide Brachytherapy Source (RTx-RBS) is indicated for episcleral brachytherapy of umors and benign growths.

    The RTx-RBS is intended for use within a compatible manual brachytherapy applicator system.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA clearance letter for a medical device called "RadianceTx Radionuclide Brachytherapy Source (RTx-RBS)". This document type does not include information about acceptance criteria or a study proving the device meets those criteria.

    FDA clearance letters affirm that a new device is "substantially equivalent" to a predicate device already on the market, meaning it performs as safely and effectively as a device already legally marketed. For such clearance, the FDA does not require a new clinical study to establish acceptance criteria and prove its performance in the same way a Premarket Approval (PMA) application would.

    Therefore, I cannot extract the requested information from the provided text.

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