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510(k) Data Aggregation

    K Number
    K170144
    Device Name
    StentBoost Live
    Date Cleared
    2017-06-07

    (141 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Medical Stystems Nederland BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    StentBoost Live is intended to assist the physician during percutaneous coronary interventions. StentBoost Live provides real-time enhanced visualization of stents. StentBoost Live provides real-time enhanced visualization of stents in relation to coronary vessels. StentBoost Live assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of coronary stents. StentBoost Live is suitable for use with the entire adult human population. StentBoost Live is a software medical device and does not come in contact with a human subject.
    Device Description
    StentBoost Live is a software medical device intended to provide enhanced visualization of stents in coronary vessels in real-time. It supports the physician in placing and deploying stents. The StentBoost Live is connected to a Philips interventional X-ray System and uses X-ray generated data as input. StentBoost Live uses radiopaque balloon markers to provide real-time stent enhanced visualization by displaying a motion compensated average stent image. StentBoost Live provides X-ray System integration with the Philips interventional X-ray System to allow automatic power on and off of StentBoost Live. In addition the user interactions can be controlled from the table-side of the X-ray System. StentBoost Live provides the option for the physician to create DICOM compatible snapshots and movies of the enhanced image for reporting and archiving when connected to a picture archiving and communication system (PACS).
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