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510(k) Data Aggregation

    K Number
    K121845
    Device Name
    SDX SYSTEM
    Manufacturer
    Date Cleared
    2012-10-19

    (116 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYN'R SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SDX is intended for use in Radiation therapy as an aid in allowing the patient and treatment staff to visualize a patients breathing process and to optimize breathing to limit internal motion during imaging & treatment. The SDX System including the Automatic Gating Module is used to provide respiratory synchronization for radiation therapy imaging & treatment.
    Device Description
    The SDX Systems are intended to be used in conjunction with a Radiation Therapy systems (imaging & treatment) requiring operator intervention to start & stop radiation. The Automatic Gating Module is intended to facilitate the interface between operators, whilst ensuring at all times the operators have complete control & maintain the final decision in imaging & treatment. The Automatic Gating Module provides the direct interface between the SDX Module and the Imaging / Radiation Treatment equipment; providing channels on : device communication / identification, recommendation to start Patient Imaging / Radiation, order (or recommendation) to stop patient Imaging / Radiation. The Automatic Gating Module is connected, via cabling, to the Radiation Therapy systems via their own "external interfacing equipment". The use of the Automatic Gating Module allows the SDX to optimize breathing to limit internal motion during imaging & treatment independent to the breathing method chosen, Breath Hold, Free Breathing, etc. Thus patients breathing pattern allows the selection of the gating levels, facilitate the starting & stopping of the radiation beam between the two defined levels.
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    K Number
    K092479
    Device Name
    SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
    Manufacturer
    Date Cleared
    2010-01-11

    (151 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYN'R

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SDX - SpiroDynr'X is intended for use in Radiation therapy as an aid in allowing the patient and treatment staff to visualize a patients breathing process and to optimize the time when a breath should be held to limit internal motion during treatment.
    Device Description
    SDX is a spirometer located in the imaging or treatment room, with software installed on a dedicated workstation located in the control room. In the voluntary breath hold technique, the patient is independently monitoring their breathing pattern and reproduces the effective breath hold level. The patient holds their breath at a defined volumetric level whilst imaging or radiation therapy is being carried out t under the Clinical team supervision.
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