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510(k) Data Aggregation

    K Number
    K254089

    Validate with FDA (Live)

    Device Name
    IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
    Manufacturer
    Centerline Biomedical, Inc.
    Date Cleared
    2026-02-17

    (60 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K243842
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IOPS Visionary System is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

    Device Description

    The IOPS® Visionary system displays the position and orientation of sensor-equipped IOPS guidewires and IOPS catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously-acquired scan data (CT). IOPS Visionary tracks the location and orientation of the sensors in real time, superimposing navigation of the IOPS Catheter and IOPS Guidewire to the patient's vascular map.

    The system consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact, reusable, multi-patient use device. The associated accessories are single use devices provided sterile (EtO).

    The IOPS Visionary System is indicated for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic, and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS Visionary System does not make a diagnosis.

    The associated accessories include:
    • Guidewire
    • Catheters
    • Fiducial Tracking Pad
    • Guidewire Handle

    The system consists of three major sections: the cart, the tracking system (Interface Module, System Control Unit and Field Generator) and the accessories.

    AI/ML Overview

    N/A

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