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Interactive, image-guided means of localizing targets in surgical procedures. OTS is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The above device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point is tracked using light emitting diodes (LEDs) attached to the microscope and viewed by a camera array in conjunction with digital communications with the microscope.

The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The Optical Tracking System (OTS) provides an interactive, image-guided means of localizing targets in surgical procedures. A camera array tracks the position of probes and various tools. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon registration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.

XPlan-1 is a stereotactic LINAC-based radiation treatment planning system. XPlan-1 localizes lesions to be treated using CT scans, MR scans and digitized angiographic film. XPlan-1 provides a stereotactic planning system, for treatment of tumors < 7 cm in diameter at sites such as base of skull and head. The conformal stereotactic treatments are delivered over multiple fractions.

The XPlan-1 system has the same intended use and similar technological characteristics as the commercially available XKnife-3 Stereotactic Radiation Treatment Planning System. Like XKnife-3, the XPlan-1 system includes the same image acquisition, localizing, contouring and beam planning techniques. In addition, XPlan-1 and XKnife-3 both contain methods of QA verification for targeting setup and delivery. XPlan-1 includes modifications of the XKnife-3 system, such as the ability to use conformal collimation devices and a modification to the dose algorithm to account for the use of conformal collimation devices. XPlan-1 also supports the use of the Laser Angio Target Localizer (LATL) as an additional QA check to verify the orientation and position of the LINAC jaws and gantry, the collimator and couch rotation. Like the XKnife-3 use of the Rectilinear Phantom Pointer (RLPP) and Laser Target Localizer Frame (LTLF), XPlan-1 supports the use of the LATL to confirm system alignment at isocenter and to position the patient at isocenter. XPlan-1 is also substantially equivalent to the commercially available Conformal Radiation Treatment Planning System, FOCUS. Like FOCUS, XPlan-1 supports the use of LINAC jaws, MLCs and wedges to modify the shape and attenuation of the beam. Both XPlan-1 and FOCUS also have the ability to model the total on the target volume and surrounding tissue via a 3D Beam's Eye View and 2D beam visualization. Both systems, also addition to the dose-volume histogram.

The Optical Tracking System (OTS) is a graphical planning tool that allows for preoperative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.

OAS is a surgical planning system which enables the surgeon to plan a surgical procedure so as to optimize his approach. The OAS provides the surgeon with visual information to make assessments during a surgical procedure. OAS is indicated for the operative planning of surgical procedures, for example: tumor resection, ventricular shunt placement, craniotomy, and ENT- intranasal ethmoidectomy.

The Operating Arm System, addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System (with CT images) and the ISG Viewing Wand System. New features described in this submission include the additional support of MR images and Radionics adhesive fiducial markers. The OAS provides an interactive, imageguided means of localizing targets in surgical procedures. It consists of an articulated Operating Arm, a computer workstation, application software, probes, and a Mayfield Attachment. The Operating Arm consists of a series of articulating joints and connecting links combined with an instrument holder. It is a five-jointed, five degree of freedom pointing device used for position (x, y, z) and angle measurement. Upon calibration of the instrument in the surgical environment, the surgeon manipulates the Arm to select points in surgical space which are interpreted by the computer and related to corresponding points in image space. Similarly, the ISG Viewing Wand System consists of an articulated Arm, a computer workstation, application software, probes, and a Mayfield Attachment. It is a six-jointed six degree of freedom electrogoniometer used for position (x, y, z) and angle measurement.

The Dental Tray holds an impression of the upper teeth, and is part of the GTC Relocatable Head Holder in stereotactic collimated beam, computer planned, LINAC (linear accelerator) based treatment. The Dental Tray holds the dental impression. The dental impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments.

The Dental Tray holds an impression of the upper teeth as part of the predicate system. This impression allows repeat positioning of the stereotactic frame at the same location, e.g., for multiple lower dose fractionated stereotactic radiotherapy treatments. The material of the GTC Dental Tray has been modified from that described in (K934523). The GTC Dental Tray addressed in this 510(k) PMN has the same intended use, design, and technological characteristics as the Dental Tray included in the commercially available GTC Relocatable Head Holder System (K934523).

Image processing and comparing an MR and a CT image set or two different CT image sets.

The ImageFusion system, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available StereoPlan system. Like StereoPlan, the ImageFusion system includes an image processing work station used to evaluate, manipulate, and compare MR and CT image data. In addition, ImageFusion software can reconstruct (fuse) nonstereotactic MR images into the image space of a reference CT stereotactic image set for subsequent stereotactic use, eliminating the need for the localizing hardware required in StereoPlan to define stereotactic locations in MR images. Subsequently, fused images can be used in the treatment planning for stereotactic neurosurgery, radiosurgery and radiotherapy procedures in the same way that supplementary stereotactic MR or CT images are utilized in StereoPlan.