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510(k) Data Aggregation

    K Number
    K112969
    Device Name
    AIR-BAG SYSTEM
    Manufacturer
    NIIGATA MECHATRONICS CO., LTD.
    Date Cleared
    2012-03-14

    (161 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of this Air-Bag System is to monitor patient's respiratory cycle and to fix the trunk of the body of patient during radiation therapy.

    This Air-Bag System can properly press the abdomen and stabilize patient's positioning repeatability easily in continuous radiation therapy.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for an "Air-Bag System" intended to monitor a patient's respiratory cycle and fix the trunk during radiation therapy. It is not an AI/ML powered device, therefore no information about acceptance criteria and studies are provided.

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