2 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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.
FDA Enforcement
Class II
·Terminated·Brainreader ApS·February 10, 2021
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.
FDA Recall
Terminated
·Brainreader ApS Emil Mollers Gade 41 REGION Horsens Denmark·Product code LLZ·December 14, 2020