BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S012 · Decision Apr 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Mr-Guided Focused Ultrasound System
    Trade Name
    ExAblate 4000 System (Exablate Neuro or the system)
    PMA Number
    P150038
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    POH
    Generic Name
    MR-guided focused ultrasound system
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 14, 2020
    Date Received
    August 8, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the Exablate Neuro to introduce software version 7.33, expand the use of the device with an additional Siemens 1.5 Tesla (T) Aera magnetic resonance imaging (MRI) scanner, and addition of a custom 1.5 T receive-only imaging coil for the Exablate 4000 Type 1.1 System and a custom 3.0 T receive-only imaging coil for the Exablate 4000 Type 1.0 System.

    Classifications

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

    Product Code Device Name
    POH Mr-Guided Focused Ultrasound System