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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?
    Applicant Name (Manufacturer) :

    Bilab

    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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