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510(k) Data Aggregation

    K Number
    K251989

    Validate with FDA (Live)

    Device Name
    VizMark Preloaded Tissue Marker Device (VM-0001)
    Manufacturer
    Breast-Med, Inc.
    Date Cleared
    2025-12-12

    (168 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K100994,K133697
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VizMark Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

    Device Description

    The VizMark Tissue Marker is a sterile, nonpyrogenic, single use tissue marker consisting of a gadolinium filled polymeric tube that is visible on standard radiographs (x-ray, mammography) as well as ultrasound and Magnetic Resonance Imaging (MRI). The tissue marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. VizMark Preloaded Tissue Markers are supplied pre-loaded in a sterile, single patient use delivery device.

    AI/ML Overview

    N/A

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