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510(k) Data Aggregation

    K Number
    K013419
    Device Name
    NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
    Manufacturer
    NICOLET BIOMEDICAL
    Date Cleared
    2001-12-20

    (66 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

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

    The NEN provides intra-operative image guidance during neurosurgical operations. The NEN provides and operation and provides feedback and provides feedback concerning actions performed and parameters set.

    Device Description

    Nicolet Biomedical Electromagnetic Navigation System

    AI/ML Overview

    This is a regulatory letter from the FDA regarding the 510(k) premarket notification for the "Nicolet Biomedical Electromagnetic Navigation System." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, the letter does not contain the acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document is a marketing authorization letter, not a study report or a summary of performance data.

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