Avatar Medical Vision

Avatar Medical Vision is a software-only medical imaging system that processes and displays CT and MR image data in three-dimensional format on standard computer screens, autostereoscopic displays, and VR headsets. It is intended for preoperative surgical planning and intraoperative display of multi-dimensional images by healthcare professionals in hospitals and clinics.

The subject device adds autostereoscopic display capability and non-linear/volumetric measurements compared to the predicate device, which only supported standard non-stereoscopic displays and linear/diameter measurements. Both devices support interactive manipulation, manual segmentation, annotations, and image panning, with both intended for preoperative and intraoperative use in healthcare settings.

EN 62304:2006/A1:2015 (Medical device software – Software life cycle processes), IEC 63145-20-20 (VR headset optical testing), and FDA Guidance documents on software submissions and cybersecurity in medical devices. Performance testing included measurement accuracy using digital phantoms, display quality evaluation (luminance, contrast, resolution), and system fluidity assessment via Frame Per Second rates.

Avatar Medical Vision is substantially equivalent to AVATAR MEDICAL Software V1 (K222035) because both devices have the same intended use for viewing multi-dimensional CT/MR data for preoperative and intraoperative surgical planning by healthcare professionals. The addition of autostereoscopic display and volumetric/non-linear measurements does not raise new safety or effectiveness questions, as performance testing confirms acceptable display quality and measurement accuracy for the intended clinical use.