Avatar Medical Vision
Avatar MedicalAvatar Medical Vision is a software device that enables healthcare professionals to process, review, and analyze 3D CT and MR images on standard or specialized displays such as VR headsets and autostereoscopic screens. It assists in preoperative surgical planning and intraoperative display of imaging, making medical image data more interactive and accessible to clinicians during surgical procedures.
Intended Use
Intended as a medical imaging system for processing, review, analysis, communication, and media interchange of CT and MR images; software for preoperative surgical planning and intraoperative display on standard or autostereoscopic screens and VR headsets.
Technology
Software-only device enabling 3D visualization of CT and MR images on standard, autostereoscopic, and VR displays. The software features user interfaces for 2D, 3D, autostereoscopic, and VR image review, along with capabilities for measurement, annotation, and manual segmentation. Compatible with specific hardware for autostereoscopic display and VR headsets, providing immersive image manipulation for surgical planning and intraoperative use in non-sterile environments.
Performance
Performance validation included software verification and validation testing per relevant standards and FDA guidance, measurement accuracy testing with digital phantoms, display quality assessment for luminance, contrast, resolution, and frame rate. Filter functioning was visually inspected. Additional optical tests consistent with IEC 63145-20-20 and manufacturer testing ensured VR and autostereoscopic display quality.
Predicate Devices
No predicate devices specified
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