BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    PMA: P040003 · Supplement: S002 · Decision Feb 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
    Trade Name
    EXABLATE 2000
    PMA Number
    P040003
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    NRZ
    Generic Name
    Ablation system, high intensity focused ultrasound (HIFU), MR-guided
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 27, 2007
    Date Received
    July 17, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT THE VERSION 4.2 SOFTWARE AND A NEW PATIENT TABLE (WITH OTHER RELATED HARDWARE) THAT ALLOW FOR OPERATION OF THE EXABLATE 2000 SYSTEM WITH THE GENERAL ELECTRIC 3T MAGNETIC RESONANCE IMAGING (MRI) SYSTEM. VERSION 4.2 SOFTWARE PROVIDES FOR AN INTERLEAVED MODE OF OPERATION, ELONGATED FOCAL SPOTS, AND A SCALE-ABLE COOLING DURING.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRZ Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided