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510(k) Data Aggregation

    K Number
    K201798
    Device Name
    myQA iON
    Manufacturer
    IBA Dosimetry GmbH
    Date Cleared
    2020-07-17

    (17 days)

    Product Code
    LHN, IYE, IYI, SEC
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBA Dosimetry GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the myQA iON product is to perform patient quality assurance activities for radiation therapy treatment delivery systems. myQA iON is a software toolbox allowing the Medical Physicist to perform quality assurance activities before and after the patient treatment fractions for all patients undergoing radiation therapy.
    Device Description
    The myQA iON product is a server-based software application for performing patient quality assurance for radiation therapy. In its full scope, the product delivers means for the verification of: - The patient treatment plan prior to the first treatment fraction by - Using an independent dose algorithm to compute a dose map based on the patient treatment plan; - Performing measurements using external measurement devices and analyzing the results; - Performing machine log analysis during a treatment dry run session and reconstructing the delivered dose. - The patient treatment delivery by - Performing machine log analysis and reconstructing the delivered dose for each treatment fraction. In its full scope, the product interfaces with the Treatment Planning System, the Oncology Information System, the treatment delivery System and the external measurement device.
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    K Number
    K191821
    Device Name
    Blue Phantom PT
    Manufacturer
    IBA Dosimetry GmbH
    Date Cleared
    2020-01-23

    (199 days)

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

    IBA Dosimetry GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Blue Phantom PT is to move detectors in one dimension within a water tank. It transfers indicated ionization beams (proton beams) at a certain position into electrical signals.
    Device Description
    The Blue Phantom PT system consists of a water tank with a one-dimensional servo including a common control unit (CCU PT) with integrated two-channel electrometer. An ionisation chamber (e.g. Stingray) is placed inside the Blue Phantom PT with a holder and is used as detector for measurements. The Blue Phantom PT is intended to be used in the magnetic environment of a proton therapy treatment unit and its technology has been designed to meet those requirements. On the horizontal Y-rail, detector holders for various detectors can be mounted on a sliding shoe. The detector can be positioned in the Y-direction for measuring horizontal beams.
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    K Number
    K092018
    Device Name
    OMNIPRO INCLINE
    Manufacturer
    IBA DOSIMETRY GMBH
    Date Cleared
    2009-09-18

    (74 days)

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

    IBA DOSIMETRY GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OmniPro Incline is a QA beam measuring system intended to be used for the verification of dose distribution in radio therapy. The system is intended to measure proton, photon and electron beams.
    Device Description
    The Omni-Pro-Incline software is a workspace tool managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET): The software is delivered with a dedicated system of multi layer of ionization chambers and with a decicated electrometer based on the Tera chip technology. Single Bragg peaks as well as modulated distributions can be measured and analyzed with high spatial and temporal resolution (in the order of 2mm WET) with typical sampling time down to 10ms. The data format will be directly compatible with the one of the IBA Dosimetry conventional formats and at least easily exchangeable. The system is suitable for both active and passive delivery
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