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The XR90 (XR90-SYS) is a medical display workstation intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from tracked Ultrasound, tracked interventional device, and 3D volumetric data acquired from CT sources and stereoscopically projected such that the proximity of the virtual interventional device is displayed relative to live ultrasound and 3D models from previously acquired CT. The device is intended to provide visual information and reference to be used by the health care professionals for analysis of surgical options during pre-operative planning, and the heads-up, intra-operative display of the images during ultrasound-guided needle-based procedures. Virtual images on the heads-up display should always be used in conjunction with traditional monitors. The XR90 (XR90-SYS) system 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. The XR90 (XR90-SYS) system is intended to be used as a reference display for consultation and guidance to assist the clinician who is responsible for making all final patient management decisions. During system use, the position and orientation tracking of the interventional instruments should always be available to the clinician on traditional imaging and monitors.

The MediView™ XR90 (XR90-SYS) system is an augmented reality-based medical device to be used adjunctively to clinical ultrasound (US) systems, with the ability to stereoscopically project and fuse standard-of-care US with digital anatomical models based on pre-procedural computed tomography (CT) imaging in biopsies and percutaneous ablations to overcome the limitations of two-dimensional image fusion. The XR90 (XR90-SYS) system provides visual information and remote collaboration features. XR90 (XR90-SYS) and cleared image fusion devices spatially register and project virtual representations of a) tracked interventional instruments and b) imaged patient anatomy in a common coordinate system. Accordingly, the use of XR90 (XR90-SYS) involves the co-registration of virtual objects (tracked device, US, and CT) for visual information and does not involve use of stereoscopic projection to physical (i.e., real-world) anatomy for navigation, consistent with predicate devices. XR90 (XR90-SYS) spatially registers and stereoscopically co-projects three types of virtual objects: (1) Holographic Light Ray (HLR), (2) CT-based virtual anatomy, and (3) live ultrasound b-sector (Flashlight) with the HUD ultrasound display/augmented reality user interface, while maintaining the same principle of operation compared to predicate devices. Accordingly, the paired registration of holographic entities are: - (1) HLR and virtual US-sector (Flashlight), - (2) CT-based virtual anatomy and virtual US-sector (Flashlight), and - (3) HLR and CT-based virtual anatomy. The system is comprised of a commercial, off-the-shelf augmented reality head-mounted display, wirelessly connected to a streamer which interfaces with a GE Vivid iq ultrasound system and an electromagnetic (EM) field generator. The US signal is transmitted from the streamer to the headmounted display, where a virtual display of the US image is stereoscopically projected into the user's field-of-view in conjunction with pre-acquired CT-based images and tracked instrumentation. The XR90 (XR90-SYS) system is capable of teleprocedural collaboration through the head-mounted display using Microsoft Dynamics 365 Remote Assist, allowing for other healthcare professionals to securely connect remotely to the head-mounted display, viewing the US signal and communicating (both through voice and needle annotation on the screen) in real-time with the local proceduralist. The remote collaborator may interact with the proceduralist via mobile device, laptop, desktop, or head-mounted display but the collaborator participates as an observer and should not make care decisions. The combination of teleprocedure communication and Holographic Needle Guide features provide workflow and ergonomics to the user for pre-operative planning and intra-operative display of virtual images. XR90 (XR90-SYS) is intended to be used adjunctively to standard of care imaging and provides guidance to the user. Proceduralists must refer to standard of care (conventional monitors) and prioritize clinical experience and/or judgement when using the XR90 (XR90-SYS) system.