Indications for Use
Released: 13 February, 2018
Viz LVO Platform is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.
Viz LVO Platform uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting, and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application.
Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. Viz LVO Platform is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.