BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NAVIGUS II MR

    K Number: K012719 · Decision Oct 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    22
    Review Days
    69

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NAVIGUS II MR
    K Number
    K012719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Image-Guided Neurologics, Inc.
    Date Received
    August 14, 2001
    Decision Date
    October 22, 2001
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HAW), ordered by most recent decision date.

    Zeta Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stealth AXiS Cranial clinical application

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroAlign software

    FDA 510(k)
    FDA Class 2 ·Neurology

    SOLOPASS 2.0 System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ball Joint Guide Array (66295)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EZ-FIDUCIALS

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Image-Guided Neurologics, Inc.

    K Number Device Name
    K050772 NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
    K043091 NAVIGUS NEXDRIVE, MODEL MI-3000
    K040334 NAVIGUS PASSIVE PROBE, MODEL NP-1000
    K040834 NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
    K033619 NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
    K031885 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
    K024201 NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
    K023949 NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
    K022100 NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
    K012366 NAVIGUS II TRAJECTORY GUIDE
    Search all 22 clearances from Image-Guided Neurologics, Inc. →