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510(k) Data Aggregation

    K Number
    K024103
    Device Name
    IVUS PLUS
    Manufacturer
    INDEC SYSTEMS, INC.
    Date Cleared
    2003-01-24

    (43 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K891386,K921750,K933517,K930311,K965223,K980851
    Why did this record match?
    Reference Devices :

    K891386, K921750, K933517, K930311

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

    IVUS Plus is a digital image processing accessory to Boston Scientific's intravascular ultrasound imaging systems, ClearView (K891386) and Insight (K921750). It adds fulllength longitudinal digital display capability, full image rotation capability, and mensuration functions. It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy

    Device Description

    IVUS Plus will function as an accessory to ClearView and Insight (K891386 and K921750), Boston Scientific's intravascular ultrasound imaging systems. IVUS Plus adds digital image review capability and full-length longitudinal display with full image rotation and mensuration functions.

    AI/ML Overview

    The provided document is a 510(k) summary and FDA clearance letter for a device called "IVUS Plus." This device is described as a digital image processing accessory for intravascular ultrasound imaging systems, adding features like full-length longitudinal digital display, image rotation, and mensuration functions.

    However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or performance metrics. The FDA clearance is based on substantial equivalence to predicate devices, meaning it has a similar intended use, design, and operational characteristics to previously approved devices, not necessarily a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

    Therefore, I cannot provide the requested information from the given text. The provided document is a regulatory approval, not a scientific study report.

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