Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
US Nationwide distribution including in the states of UT, PA, FL, AL, CA, MN, MD, MO, VA, DC, IL, TX, TN, MI, NY, IN, WA, WI, GA, MA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0934-2021