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510(k) Data Aggregation

    K Number
    DEN150011
    Device Name
    Sonablate 450
    Manufacturer
    SonaCare Medical, LLC.
    Date Cleared
    2015-10-09

    (200 days)

    Product Code
    PLP
    Regulation Number
    876.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SonaCare Medical, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonablate® 450 is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
    Device Description
    The Sonablate® 450 is a computer-controlled device designed for transrectal delivery of high intensity focused ultrasound (HIFU) energy to the prostate to ablate regions of unwanted prostatic tissue via thermal ablation. The device makes use of integrated biplanar ultrasound imaging for real-time monitoring, planning, and pre- and post-ablation imaging of the prostate. The system consists of the following main components: Sonasource Console, Sonablate Probe 30/40, Sonachill, Sonablate Multi-Axis Stepper and Probe Arm, and Single Use Components (Probe Tip Kit and Water Path Kit).
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