SurgicalAR
MEDIVIS, Inc.SurgicalAR is a software platform that allows clinicians to view and manipulate medical images in both traditional 2D and advanced 3D formats, including augmented reality via head-mounted displays. It aids surgical planning and medical image review by providing tools such as image manipulation, measurements, and 3D visualization of CT and MR images. This enhances the understanding of complex anatomical structures to improve clinical decision making.
Intended Use
Software device for display of medical images and other healthcare data, including image review, manipulation, basic measurements, and 3D visualization (MPR reconstructions and 3D volume rendering).
Technology
Software platform that loads patient CT and MRI DICOM data, enabling viewing on traditional monitors or augmented reality head-mounted displays using hand gestures. Supports image manipulation tools such as zoom, pan, window level adjustments, and 3D volume rendering. Provides visualization in multiple planes and 3D models to assist surgical planning.
Performance
Design verification and design validation, including human factors and usability testing, were successfully conducted. Tests confirmed that design outputs met inputs, no unacceptable risks identified, and user interface supports safe interaction without additional risks to safety or efficacy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/25/2019
1 month - 2
FDA Approval
5/13/2019
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