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510(k) Data Aggregation
K Number
K121845Device Name
SDX SYSTEM
Manufacturer
Date Cleared
2012-10-19
(116 days)
Regulation Number
892.5050Why 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
K092479Device Name
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
Manufacturer
Date Cleared
2010-01-11
(151 days)
Regulation Number
892.5050Why 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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