Viz Subdural+, Viz SUBDURAL PLUS

“The Viz Subdural+ (Subdural Plus) device is intended for automatic labeling, visualization and quantification of collections in the subdural space from a set of Non-Contrast Head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of collections in the subdural space identified on NCCT images.”

“Both the subject and predicate devices use an artificial intelligence algorithm to identify, label and quantify measured quantities in NCCT imaging of the head from images acquired at a single time point. Both the subject and predicate devices use software algorithms that incorporate artificial-intelligence to perform as intended. Both devices' algorithms automatically receive, assess the applicability of received input imaging, and automatically process and measure supported imaging. Both devices' algorithms use similar pipelines with similar steps to measure their indicated structures and both devices' algorithms use deep-learning convolutional neural networks with similar architectures.”

“Viz Subdural+ is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to process and analyze non-contrast CT (NCCT) scans of the head to automatically measure the collections in the subdural region in the brain and midline shift.”