BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S005 · Decision Sep 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Mr-Guided Focused Ultrasound System
    Trade Name
    Exablate Model 4000 System
    PMA Number
    P150038
    Supplement Number
    S005
    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
    September 20, 2018
    Date Received
    February 20, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Exablate 4000 Type 1.1 System, an expansion of the Exablate 4000 Type 1.0 System to add compatibility with Siemens 3T Skyra, Prisma and PrismaFIT MR systems, including hardware changes to the devices Helmet System, changes to the electronics of the devices Front End Cabinet, and changes to the device sub-systems required for connectivity with these Siemens MRI systems.

    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