BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Mr-Guided Focused Ultrasound System

    PMA: P150038 · Supplement: S013 · Decision Jul 22, 2021
    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 Type 1.0 and 1.1 System (“Exablate Neuro”)
    PMA Number
    P150038
    Supplement Number
    S013
    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
    July 22, 2021
    Date Received
    October 23, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design changes to the Exablate Model 4000 Type 1.0 & 1.1 System (Exablate Neuro) to address the end-of-life of some of the system components; to support Exablate Neuro Type 1.1 imaging quality improvements to align with the imaging quality improvements approved for the Exablate Neuro Type 1.0 and to address minor software version 7.33 defects and usability aspects.

    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