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510(k) Data Aggregation

    K Number
    K962615
    Device Name
    TUMORLOCALIZER MRI
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1998-03-19

    (624 days)

    Product Code
    MIG
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K863848,K914941,K915417,K863090,K920816
    Why did this record match?
    Product Code :

    MIG

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

    The device is intended for use to identify by standard radiologic mark or techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.

    Device Description

    The TumorLocalizer MRI is a standard needle and hookwire device used for the localization of non-palpable lesions.

    AI/ML Overview

    The provided document is a 510(k) summary for the "TumorLocalizer MRI" device, a surgical needle and hookwire device for localizing non-palpable lesions. It primarily addresses the regulatory approval process and states substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific performance criteria.

    Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory compliance and not on detailed performance studies or statistical data.

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