BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110039 · Supplement: S008 · Decision Jan 25, 2018
    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 2100/2100 VI System
    PMA Number
    P110039
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    NRZ
    Generic Name
    Ablation system, high intensity focused ultrasound (HIFU), MR-guided
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 25, 2018
    Date Received
    September 22, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) Software maintenance update to the currently approved clinical software (SW) Versions 6.24 (Windows-XP)/6.241 (Windows-7) used in the Exablate Model 2100/ 2100V1 Type 1.1 / Type 1.11 System (referred to as Exablate Bone or the system). The new software revision will be Version 6.57 (Windows-XP)/6.58 (Windows-7) (6.57 is a set of enhancements to the SW; 6.58 is an update to Windows 7 OS compatibility); and 2) Addition of a water bag as an accessory for acoustic coupling. The water bag will be provided as an optional accessory to be used as an alternative to the previously-approved gel pad.

    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