FDA-Device2021-02-10Class II
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.
Brainreader ApS
Hazard
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Sold states
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.
Affected count
43 sites have had access
Manufactured in
Emil Mollers Gade 41, REGION, Horsens, Denmark
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0934-2021Don't want to check this manually?
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