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.

Reason: The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.

Code information: Version 2.4

Distribution pattern: 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.