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CarnaLife® Holo is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, annotations, and 3D visualization. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. CarnaLife® Holo software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians. When accessing CarnaLife® Holo software from a wireless stereoscopic head-mounted display (HMD), images viewed are for informational purposes only and not intended for diagnostic use.

CarnaLife® Holo is a Software as a Medical Device (SaMD) to be used by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians, and technicians for the visualization of medical images in 3D to allow for surgical planning activities. The device makes it possible to visualize 3D Digital Imaging and Communications in Medicine (DICOM) files using volume and surface rendering in 3D to be viewed on a classic display or on a stereoscopic, holographic display. CarnaLife® Holo is intended to be used in operating rooms; office environments within hospitals or at any other location with a computer; and for informational purposes only at any location using the head-mounted display (HMD). The images can be viewed on desktop PCs with a monitor allowing the interaction with CarnaLife® Holo to be performed with a mouse and/or keyboard; and on an HMD, where the interaction with CarnaLife® Holo is performed using hand gestures, voice commands and virtual menus. CarnaLife® Holo is used to: - Load patient DICOM data; ● - . Image review, image manipulation, basic measurements, annotations, and 3D visualization; and - . View DICOM data using a traditional computer monitor, display monitors used for reading medical images for diagnostic purposes, or in mixed reality (MR) using a head-mounted display (HMD).