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BriefCase-Quantification of Midline Shift (MLS)by Aidoc

Contact Information

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

Release Stage

FDA Cleared, Commercial (K232083)

Release Date

November 2023

Version

MLS-01

Regulatory Approval

Please find attached the MLS-01 510(k) summary.

Global Availability

US, EU (CE Marked), UK (UKCA Marked), Canada (MDEL), Israel (AMAR), UAE and South Africa.

Summary

A concise overview of what this solution does and why it exists.

About

Brief Case-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older. The device is intended to assist appropriately trained medical specialists by providing the user with an automated current manual process of measuring midline shift. The device provides midline shift measurement from NCCT images acquired at a single time point, and can additionally provide an output with comparative analysis of two or more images that were acquired in the same individual at multiple time points. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.

Uses and Directions

Who it’s for, how it’s used, and where it applies in care.

Intended Use

The Brief Case-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older. The device is intended to assist appropriately trained medical specialists by providing the user with an automated current manual process of measuring midline shift.

Primary Users

Brief Case-Quantification of Midline Shift is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for midline shift measurement include radiologists, emergency physicians, surgeons, interventionalists, and neurologists.

How to Use

BriefCase-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older. The device is intended to assist appropriately trained medical specialists by providing the user with an automated current manual process of measuring midline shift. The device provides midline shift measurement from NCCT images acquired at a single time point, and can additionally provide an output with comparative analysis of two or more images that were acquired in the same individual at multiple time points

Target Population

Adults or transitional adolescents aged 18 and older.

Cautioned Out-of-Scope Settings

Out of scope

results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care. Only for use by appropriately trained medical specialists. Please refer to BriefCase-Quantification User Guide (UG0010) 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.