BriefCase-Triage for Brain Aneurysm
Contact Information
www.aidoc.com/contact-support/ or email:info@aidoc.com
Release Stage
Release Date
Version
Regulatory Approval
Please find attached the BA-01 510(k) summary.
Global Availability
US, EU (CE Marked), UK (UKCA Marked), Canada (MDEL), Australia (ARTG), New Zealand, Israel (AMAR), UAE and South Africa.
Summary
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CT Angio (CTA) images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of Brain Aneurysm (BA) findings above 5 mm size.
BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of BriefCase are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Uses and Directions
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CT Angio (CTA) images. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of Brain Aneurysm (BA) findings above 5 mm size.
Primary Users
The Brain Aneurysm solution is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for BA are Emergency physicians, radiologists, neurologists, neuro-surgeons, neuro-interventionalists, interventional radiologists, neuro intensive care physicians.
How to Use
The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
Target Population
patients Adults or transitional adolescents aged 18 and older.
Cautioned Out-of-Scope Settings
Cautioned Out-of-Scope Settings
Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Only for use in workflow triage, and only for use by appropriately trained medical specialists. Please refer to BriefCase-Triage User Guide (UG0009) for further information on warnings and precautions.
EHR Compatibility
EHR-agnostic
This solution works independently of specific EHR systems and can be integrated with most healthcare IT infrastructures.