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510(k) Data Aggregation

    K Number
    K031885
    Device Name
    NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2003-08-21

    (64 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

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

    Intended Use: The Navigus Passive Head Restraint System is intended for use in neurosurgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "Navigus Passive Head Restraint System." This document does not contain information about acceptance criteria, study details, or device performance metrics. It primarily serves as an approval letter, stating that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given text. The text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any tests.
    3. Number or qualifications of experts.
    4. Adjudication methods.
    5. Information about MRMC comparative effectiveness studies.
    6. Details about standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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