The OpenSight Augmented Reality System is the first AR medical solution for Microsoft HoloLens cleared by the FDA receiving 510(k) clearance for use in pre-operative surgical planning.
OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for pre-operative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation.
OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis.
OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand the anatomy and pathology of the patient.
The OpenSight Augmented Reality system uses the Microsoft HoloLens hardware and the Microsoft 10 Operating System as the platform on which this system runs. The OpenSight technology is written specifically for this hardware.
(“Novarad OpenSight 510(k) Submission | 2018,” 2018, p. 5)