BEUDAMED
    Product Code: PZC FDA not classified

    Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue

    Unknown

    The Ablation System, High Intensity Focus Ultrasound (HIFU), Soft Tissue is an image-guided focused ultrasound system intended to heat and ablate soft tissue using high intensity focused ultrasound energy. It currently has no formal FDA classification (device class "N") and no assigned regulation number, as it is under review through the De Novo pathway. The product code is PZC, reviewed by the Surgery (SU) panel. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PZC
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue.

    Unclassified Reason

    3

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.