BriefCase-Quantification of Midline Shift (MLS)
Contact Information
www.aidoc.com/contact-support/ or email:info@aidoc.com
Release Stage
Release Date
Version
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
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
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
Cautioned Out-of-Scope Settings
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.