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BriefCase-Triage for Aortic Dissection

by Aidoc

Contact Information

www.aidoc.com/contact-support/ or email:info@aidoc.com

Release Stage

FDA Cleared, Commercial (K222329)

Release Date

September 2022

Version

AD-01

Regulatory Approval

Please find attached the AD-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

The Aortic Dissection solution is a radiological computer-aided triage and notification software indicated for use in the analysis of CT exams with contrast (CTA and CT with contrast) that include the chest in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) pathology. BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. 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 the user's 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

The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) pathology.

Primary Users

The Aortic Dissection solution is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for Aortic Dissection are emergency physicians, radiologists, cardiologists, and interventional radiologists.

How to Use

The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The results of the Aortic Dissection solution are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images.

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.