LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251367

    Validate with FDA (Live)

    Device Name
    OptoMonitor 3
    Manufacturer
    Opsens, Inc.
    Date Cleared
    2026-01-16

    (260 days)

    Product Code
    DXO
    Regulation Number
    870.2870
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K241418
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K241418

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures.

    Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

    Device Description

    The OptoMonitor 3 with Display Unit Software update to v1.3.0 and Capture Unit when compared to the OptoMonitor 3 cleared under K241418 includes the following changes:

    New PhysioVU Software Functionality:

    The PhysioVU functionality added to the OptoMonitor 3 provides a feature designed to support the cardiologist PCI workflow by displaying a time-synchronized playback of angiogram and coronary physiological pullback values such as Pd/Pa or dPR. This feature can be utilized on angiography systems compatible with PhysioVU requirements. The validation of PhysioVU's compatibility and overall latency performance was evaluated on three representative angiography systems at 7.5 fps and 15 fps.

    dPR Pullback:

    A dPR Pullback display optimization has been incorporated to meet the time-synchronization requirements of PhysioVU functionality and is called Pullback 2. Pullback 2 provides an adequate delay between the angiography image and the dPR calculation and can be used as a standalone or a PhysioVU pullback.

    New Capture Unit (Hardware):

    The Capture Unit component is optional but required for the PhysioVU functionality. The Capture Unit is used to capture angiography images that are sent to the Display Unit. This enables the Display Unit to subsequently replay recordings of these angiograms synchronized with physiological pullback values such as Pd/Pa or dPR.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1