LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    DEN210032
    Device Name
    AccuMeasure System
    Manufacturer
    RQMIS Inc.
    Date Cleared
    2022-07-26

    (351 days)

    Product Code
    QTH, OTH
    Regulation Number
    876.1530
    Why did this record match?
    Product Code :

    QTH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AccuMeasure™ System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure™ System provides no therapeutic or diagnostic function.
    Device Description
    The device is used in conjunction with an endoscope to measure objects on the mucosal surface of the gastrointestinal (GI) tract. The device consists of two components (1) the measuring device and (2) a processing unit. The measuring device consists of a through the scope probe that is connected to a handheld laser source. The processing unit includes a video grabber and a touch screen PC. The medical-grade PC comes with dedicated software for conducting measurements during an endoscopic procedure.
    Ask a Question

    Page 1 of 1