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ERGO++ is a treatment planning system. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

description of the device such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties is in Appendix 2 and Appendix 3 of this notification.

Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR , fluoroscopic or ultrasound images. Example procedures include but are not limited to: Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies Spinal Procedures: Spinal implant procedures such as pedicle screw placement ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies. Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies

Argos is a system for computer-assisted stereotactic surgery. It is designed to be used as an aid to the location of, and surgical approach to, lesions within the anatomical structures on the human body and to help define the exact anatomical relations of such lesions to surrounding structures. Prior to the brain surgery, the Argos system acquires contiguous MRI or CT scans of the area containing the lesion and uses them to construct an accurate three-dimensional representation of the patient's anatomy used initially to facilitate surgical planning. During the operation the Argos system continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen in relation to the three-dimensional virtual anatomy of the patient. It is therefore possible to verify during the operation that the real position of various anatomical reference points, including the lesion, corresponding to those identified during surgical planning.