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510(k) Data Aggregation

    K Number
    K163206
    Device Name
    SMD-Sr90-DA Radionuclide Brachytherapy Source
    Manufacturer
    Salutaris Medical Devices, Inc.
    Date Cleared
    2016-12-15

    (30 days)

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

    SMD-Sr90-DA Radionuclide Brachytherapy Source

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

    The SMD-Sr90-DA Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy. The SMD-Sr90-DA RBS device is intended for use within a manual brachytherapy applicator system.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document (K163206) does not contain the information requested. This document is an FDA clearance letter for a medical device (SMD-Sr90-DA Radionuclide Brachytherapy Source) and includes regulatory information and indications for use. It does not provide details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications as it pertains to AI/algorithm performance. These elements are typically found in study reports or 510(k) summaries for devices incorporating artificial intelligence or machine learning.

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