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The RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a photon linear accelerator to perform Stereotactic Radiosurgery or Radiotherapy on head and neck theraputic targets that lie outside the cranium. It provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures on head and neck lesions outside the cranium. The RadioCameras™ Head/Neck Application uses fiducial markers on a biteblock to localize the treatment site on CT or MR scans and optical tracking of infrared markers on the biteblock as the method of locating the position of the treatment isocenter relative to the LINAC isocenter. The RadioCameras™ Biteblock System Head/Neck Application consists of a high resolution linear CCD camera array, computer workstation, a biteblock optical positioner, and an optical calibration jig.

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/Pallidotomies. Spinal Procedures: Spinal implant procedures, such as pedicle screw placement. ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies./Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscope images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.

This submission describes a modification to the StealthStation® System to provide for image-guided tracking of a motorized instrument placement tool.

The METRx™ Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the search and removal of nucleus material. It is intended for use in the lumbar spine. The endoscope is also indicated for use in the knee, shoulder, wrist and temporomandibular joint (TMJ).

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The Image Analysis System is intended to provide a method of storing and providing remote viewing and analyzing access to diagnostic images via a LAN, the internet, or a modem. The system is also intended to provide the display of segmented anatomical structures based on the correlation of the image sets to atlas information. Examples of structures that may be segmented include but are not limited to: vertebral bodies, prostate, hippocampus, and the basal ganglia.

This submission describes a system to display, transfer, store, analyze and process patient image sets. The processing of image data includes the ability to segment anatomical structures.

The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.

image correlation system

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.

This submission describes a modification to the StealthStation® System to provide for image guided surgery based on a fluoroscopy based model of the anatomy.

The StealthStation™ System with the Universal Attachment is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. The StealthStation™ System is also indicated for intranasal or sinus use.

This submission describes a Universal Attachment with infrared markers that allows a StealthStation® System user to image guide rigid surgical instruments.

The StealthSERVER™ Image Storage and Communication System is used to store and provide remote viewing access to diagnostic images via a LAN, the internet or modem. In addition, the system can be used to remotely set surgical plans for stereotactic surgery that are compatible with and can be accessed by the StealthStation® Treatment Guidance Platform.

This submission describes a network server system that provides remote access to digital image sets for the purpose of reviewing the images and, optionally, for developing and storing a stereotactic surgical plan that is compatible with the StealthStation® Image Guided Treatment Platform. The submission includes the capability of the StealthStation® System to retrieve the surgical plans and image sets from the network server.