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

    VIEWPOINT PASSIVE TOOL OPTION

    K Number: K990868 · Decision Mar 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    190
    Review Days
    14

    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
    VIEWPOINT PASSIVE TOOL OPTION
    K Number
    K990868
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    March 16, 1999
    Decision Date
    March 30, 1999
    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 Philips Medical Systems (Cleveland), Inc.

    K Number Device Name
    K171850 Philips CT Big Bore
    K172406 Ingenuity TF
    K162838 Philips iCT CT System
    K163711 IQon Spectral CT
    K170086 Pinnacle Radiation Therapy Planning System
    K160743 Philips Ingenuity CT
    K153444 Philips Multislice CT System with Low Dose CT Lung Cancer
    K130992 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
    K111336 EBW NM 2.0
    K111024 JETPACK 2.0
    Search all 190 clearances from Philips Medical Systems (Cleveland), Inc. →