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The Explorer ™ Liver --- Passive Tracking device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Explorer" Liver --- Passive Tracking is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver --- Passive Tracking system consists of eight (8) components which are listed below: - An image-guided surgery software platform installed on a personal computer (PC) (1) - (2) An optical position sensor --- the Polaris Spectra or Vicra that can accurately localize the tracked devices listed below in passive tracking mode - . A passive tracked abdominal reference (used for definition of coordinate and instrument calibration) - . A passive tracked Localization Pen Probe - . A passive tracked Laser Range Scanner (LRS) - Two passive tracked adapters (can be attached onto up to two rigid surgical instruments ● simultaneously and used for their localization in 3-D surgical space) - (3) An LCD display monitor.

The Explorer™ Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Explorer™ Liver system is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver system consists of six (6) components which are listed below: - An image-guided surgery software platform installed on a personal computer (PC) (1) - A three lens active-based optical position sensor that can accurately localize the tracked devices (2) listed below - A tracked adapter multi tool (used for localization of rigid surgical instruments and to (a) define 3-D surgical space) - A tracked laser range scanner (b) - A tracked Localization Probe (c) - An LCD display monitor. (3)

The PlaniSight Linasys™ device is intended for liver surgery preoperative planning. The medical image data utilized is derived from various sources, including CT and MRI scanners. The software provides tools for 3-D visualization and volume measurement of structures in the liver following manual or semi-automatic segmentation of the liver organ, intrahepatic vessels, and physician-identified lesions. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections that divide the liver and calculate margins around lesions. Data can be exported in a format suitable for image-guided surgery with the SurgiSight Linasys device. Typical users of the software are trained professionals, including physicians, nurses, and technicians.

The PlaniSight Linasys 100 Liver Surgical Planning Software (LSPS) is a self-contained, PC-based and noninvasive software application that imports medical images (CT or MRI scans) in a DICOM format. Like the predicate devices, Linasys™ LSPS is used to analyze data for preoperative planning in liver surgery. It can also output the image and model data for the use of other device, such as SurgiSight Linasys™ Image Guided Liver Surgical System (IGLSS). Linasys™ LSPS contains dedicated functions to prepare the image data and define fiducial points for use with the SurgiSight Linasys™ IGLSS system. The LSPS device also includes dedicated functions for segmentation and modeling of organ, tumor, intrahepatic vasculature, and surgical resection planes. Quantitative measurements of functional and residual liver volume allow surgeons analyze the case and make optimal liver surgical plans. Linasys 100 LSPS consists of five (5) functions: 1. Viewing image volumes & models 2. Image volume conversion 3. Anatomic fiducial point definition 4. Segmentation & modeling 5. Surgical analysis & planning

The Linasys device is indicated for open liver surgical procedures where imageguidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Linasys (Liver Navigation System) is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Linasys system consists of six (6) components which are listed below: (1) An image-guided surgery software platform installed on a personal computer (PC) (2) A three lens active-based optical position sensor that can accurately localize the tracked devices listed below (3) A tracked localization probe (4) A tracked fixed reference emitter used to define 3-D surgical space (5) A tracked laser range scanner (6) An LCD display monitor.