Brainreader ApS

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0934-2021Class IINeuroreader Medical Image Processing Software - Product Usage: intended to automate the current manuDecember 14, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K140828NEUROREADER MEDICAL IMAGE PROCESSING SOFTWAREFebruary 4, 2015