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The Thera Vision Ultrasound Ablation System, ACOUSTx Applicators, and accessories are intended for the laparoscopic, intraoperative, and percutaneous coagulation and ablation of soft tissue. It is not indicated for ablation of prostate tissue.

The TheraVision System consists of the following subsystems: - 4.1 Computer System: The computer system consists of a PC Compatible type computer running Microsoft Windows® Operating system. - 4.2 Visualization Options: Visualization options include utilization with compatible, legally marketed imaging systems. Patient images may be imported in DICOM format from MRI, CT, US, Fluoroscopic X-Ray, and PET-CT scanners. - 4.3 Software: A set of user interface and display modules allow user interaction and high-level control over the system, including power generation and safety monitoring. Top-level modules provide top level menu options and implement next-generation Microsoft Windows® display functionality. - 4.4 Thermometry System: Temperature monitoring is accomplished using an optional multichannel type T patient isolated thermocouple data acquisition system. - 4.5 RF Generation System: A Multichannel RF power generator system provides the RF enerqy needed drive the piezoelectric transducers for generation of sufficient ultrasound acoustic energy from the applicators to raise the temperature to therapeutic levels in the targeted tissue - 4.6 Cooling System: Degassed sterile water is pumped through the ultrasound transducers in the applicators and provides ultrasound energy coupling to tissue and also provides a means for cooling the applicator. ACOUSTx Applicators: The ultrasound energy generated from ACOUSTx Applicators is absorbed during treatment producing thermal therapy within the targeted tissue region. The ACOUSTx Applicators are sterile and single-use and can be utilized with the TheraVision System and may contain up to four transducers each with angular insonation patterns of 360° or 180° for application of thermal therapy.

The intended use of Acoustic MedSystems, Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HDR afterloader devices. In addition to planning and treatment, RadVision also allows volume and dose calculations, 2D and 3D analomy and dose visualizations, and post treatment seed localization. RadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants of various radioisotopes.

The RadVision system is a brachytherapy dose planning and treatment guidance system. The system consists of a computer, video capture device and software tools. The required software tools are installed in the computer. The system can be used for pre-treatment realtime dose planning in the Operating Room (OR), and for permanent seed implants performing post-implant seed localization assessment and post-implant dose distribution analysis.