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Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements, and 3D visualization. Medical images may only be interpreted using an FDA-cleared display monitor that meets technical specifications that are reviewed and accepted by the FDA. Ikshana is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Display monitors used for reading medical images for diagnostic purposes must be FDA-approved radiology monitors. Ikshana software is indicated for use by qualified healthcare professionals, including, but not restricted to, radiologists, non-radiology specialists, physicians, and technologists. When accessing the Ikshana software from a wireless stereoscopic head-mounted display (HMD) or mobile device, the images viewed are for informational purposes only and are not intended for diagnostic use.

Ikshana is a stand-alone modular software platform to be used by clinicians for the visualization of medical images in 3D to allow for surgical planning activities. The device takes 2D medical images and creates accurate 3D representations that clinicians can then view on a stereoscopic display. This modular package is used to - · Load patient CT/MR DICOM data - . View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD (Microsoft HoloLens 2).

ImmersiveTouch is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. ImmersiveTouch is also intended for measuring and treatment planning. ImmersiveTouch output can be used for the fabrication of physical replicas of the output file using traditive manufacturing methods. The physical replicas generated from digital output files are not for diagnostic purpose. ImmersiveTouch should be used in conjunction with expert clinical judgment.

ImmersiveTouch is a stand-alone modular software package that allows user to import, visualize and segment medical images to create accurate 3D representations. The 3D models can be utilized in ImmersiveTouch for measuring, treatment planning and output file to be further used as an input for additive manufacturing. This modular package includes, but is not limited to the following functions: - Importing medical images in DICOM format for visualization, segmentation, and analysis. - Viewing of medical imaging data in the axial. coronal and sagittal views. - Calculating a digital 3D model and editing the model. - Measurements on 3D models. - Treatment Planning on 3D models with cutting planes and the ability to move cut objects. - File export for 3D Printing.

Immersive View Surgical Plan (IVSP®) is intended for use as a software system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The Immersive View Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

The ImmersiveView Surgical Plan (IVSP®) system is a software based pre-surgical planning system. It is intended for use as a software system for the transfer of imaging information from a medical scanner such as CT based system. Physical outputs include surgical splints, and surgical guides that will be used in maxillofacial surgery. Surgical marking guides and surgical splints are not intended to come in contact with surgical cutting or drilling tools and therefore should not interface with surgical cutting or drilling tools. ImmersiveTouch receives patient specific medical imaging information which is further utilized by ImmersiveTouch trained employees within the ImmersiveView Surgical Plan (IVSP®) system. This includes software to extract anatomical areas of interest from 3D medical scan images and create patient-specific physical and digital outputs. Throughout the process, a physician reviews and approves the plan prior to delivery of the final outputs. Physical model outputs include surgical splints, and surgical guides for use in maxillofacial surgery. Surgical splints and surgical guides are designed and manufactured by ImmersiveTouch trained employees. Trained employees utilize the ImmersiveTouch additive manufacturing workflow to design and manufacture surgical guides, and, surgical splints using polymer resin. Surgical splints and surgical guides are provided in a NON-sterile condition and instructions for use provide the steps for cleaning and sterilization prior to use in surgery. Surgical splints and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices." Prior to use in surgery, the physician confirms the accuracy and level of precision by attaching surgical splints and surgical guides to the anatomical models are designed and manufactured using similar workflow and materials as the subject devices. Reports are generated for each patient specific case illustrating the plan and accompany the physical outputs that are delivered once verified and approved by the physician.