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510(k) Data Aggregation

    K Number
    K222466
    Device Name
    AirTom
    Manufacturer
    Bilab
    Date Cleared
    2023-06-30

    (318 days)

    Product Code
    QEB
    Regulation Number
    868.1505
    Why did this record match?
    Product Code :

    QEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirTom is a non-invasive, non-radiation medical device that provides information of local impedance variations within a cross section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs. It is intended for mechanically-ventilated patients in a professional healthcare facility, whose chest circumference is within the range of 32 ~ 130 cm. AirTom does not measure regional ventilation of the lungs.
    Device Description
    AirTom is a ventilatory electrical impedance tomograph that uses several electrodes (16+1) placed around the patient's thorax to assess regional impedance variations in a lung slice (tomography). It provides only relative measurements about variations in local impedance. AirTom estimates local impedance variations, occurring in a cross section of the thorax during a breathing cycle, which are linearly related to variations in regional air content within the lungs.
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    K Number
    K222897
    Device Name
    Enlight 2100
    Manufacturer
    Timpel S.A.
    Date Cleared
    2023-03-07

    (165 days)

    Product Code
    QEB, BZK
    Regulation Number
    868.1505
    Why did this record match?
    Product Code :

    QEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax. ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm. ENLIGHT 2100 does not measure regional ventilation of the lungs
    Device Description
    ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycle, and which are linearly related to Variations in Regional Air Content within the lung.
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    K Number
    K211135
    Device Name
    Enlight 2100
    Manufacturer
    Timpel S.A.
    Date Cleared
    2022-01-06

    (265 days)

    Product Code
    QEB, OEB
    Regulation Number
    868.1505
    Why did this record match?
    Product Code :

    QEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134cm. ENLIGHT 2100 does not measure regional ventilation of the lungs.
    Device Description
    ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycles, and which are linearly related to Variations in Regional Air Content within the lung.
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    K Number
    DEN170072
    Device Name
    Enlight 1810
    Manufacturer
    Timpel Inc.
    Date Cleared
    2018-12-20

    (447 days)

    Product Code
    QEB
    Regulation Number
    868.1505
    Why did this record match?
    Product Code :

    QEB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENLIGHT 1810 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.
    Device Description
    ENLIGHT 1810 is a non-invasive, radiation free medical device intended to provide information on the regional distribution of ventilation in a cross-sectional slice of the thorax. As the total variation in impedance for the thorax corresponds to the total tidal volume, ENLIGHT 1810 can estimate the percentage of tidal volume in regions of interest (ROI) breath by breath, measuring the contribution of the impedance variation of that ROI to the total impedance of the lung. Electrical impedance tomography (EIT) is a technique in which the electrical properties of tissues are estimated from surface electrode voltage measurements and used to provide information on Local Impedance Variation (LIV) within a cross section of a patient's thorax. Considerable electrical impedance variations are imposed on lung tissue by variations in the lung's air content. There is a linear relationship between the variations in air content and the percentage change in lung tissue impedance. This linear relationship is explored in Electrical Impedance Tomography, supporting its use as a tool to support the user's assessment of the variations in regional air content within a cross section of a patient's lungs. The device may be used on adult patients undergoing either fully controlled or assisted mechanical ventilation in the ICU environment.
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