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The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The Extended Length Tip (ELT) has been designed to be used with the 35kHz Handpiece of the CUSA Selector and CUSA NXT Ultrasonic surgical aspirators. Ultrasonic surgical aspirators facilitate the removal of cellular and other unwanted soft and hard (e.g. bone) tissue. These systems provide selective tissue disintegration with simultaneous irrigation and aspiration. The design of the 35 kHz Fine tip that is currently used with the 35kHz Handpiece has been modified to increase the working length of the device and reduce the bend angle. This will allow the device to be used in procedures where the surgeon requires a longer tip. The distal end of the ELT will have a flat annulus and two pre-aspiration holes. The ELT will be supplied sterile and is intended for single use.

The Integra Radionics™ Linac Collimator Assembly Housing (LCAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Hollder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radiosurgery (SRS) and radiotherapy (SRT).

The Linac Collimator Assembly Housing (LCAH) consisting of a collimator sliding tray, collimator baseplate, and collimator tube. It is designed as a slide-in attachment for the Siemens MLC-160 LINAC Accessory Holder. The LCAH positions and aligns Radionics radiation beam shaping collimators to the Siemens ARTISTE LINAC (K072485) internal collimator and radiation source during radiosurgery and radiation therapy procedures.

Indications For use: XKnife 5 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

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The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The CUSA Shear Tip is an additional tip that is used with CUSA EXcel system to fragment fibrous tissue. The distal end of the CUSA Shear Tip has a series of opposing angled lands, instead of a flat surface. This pattern promotes refracted longitudinal waves propagating in greatly different directions at the interface to coupled tissue. No changes to the console, handpiece or suction/irrigation system were needed.

The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy. The technological characteristics are similar to those found in the: Varian Medical Systems Trilogy Radio Therapy System 510(k) k081188 HDRT software is based on Integra Radionics ImageFusion 3 software (K063230) in that it compares multiple 3D images. In the case of HDRT the images compared are: the pretreatment planning images obtained immediately before treatment. The images immediately before treatment are obtained from Varian Trilogy Linear Accelerators which incorporate CBCT devices capable of exporting DICOM images to shared drives. Based on the comparison of the images, HDRT specifies patient adjustment data, to insure that the patient is appropriately positioned for treatment. This functionality allows for slight errors in positioning of the patient to be compensated for, it also compensates for movement of internal organs.

The CUSA Selector™ NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The CUSA Selector NXT Ultrasonic Surgical Aspirator consists of two components: System Console and Service Module. The System Console operates the full functions of the aspirator, but does not have an on-board aspiration source. The Service Module is an add-on that provides an integrated system look with a fully independent aspiration source. The product is being updated to improve usability and control technology within the system. It will utilize the existing set of Selector handpieces.

For cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System.

The Interfix Patient Adapters consists of two adapters, the InterFix™ CT Adapter which attaches to the CT scanner tabletop and the InterFix™ Tabletop Adapter for attachment to the TomoTherapy HiArt System tabletop. The adapters are designed to accept the Integra Radionics headrings, such as the Gill-Thomas-Cosman relocatable headring. Universal Compact Head Ring (UCHR), Intubation Headring Assembly (HRA-IM), and Tarbell-Loeffler Cosman (TLC) Pediatric Frame. The purpose of the Interfix system is to hold a patient securely and in the same position during the diagnostic CT scan and TomoTherapy HiArt Treatment. The adapters can be used to aid the user in aligning the patient to the lasers; however, the prescan is still required to ensure that the patient is in the correct position.

The CUSA Selector Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The Selector Integra Ultrasonic Surgical Aspirator System (Selector) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The Selector consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The Selector has been modified to enable it to fragment bone. This was accomplished by designing a new tip, which will be referred to as the Saber Tip, to work with existing system. Therefore no changes to the console, handpiece or suction/irrigation system were needed.

A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.

The above system is a pre-processing registration (fusion) software for CT, MR and PET scans. The software provides QA tools for the user to evaluate the fusion results. The results are used with other Integra Radionics applications. The software can be used on a HP UNIX or Linux workstation.

XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.