BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0934-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0934-2021
    Event ID
    86995
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainreader ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 10, 2021
    Initiation Date
    December 14, 2020
    Classification Date
    January 29, 2021
    Termination Date
    August 12, 2021
    Address
    Emil Mollers Gade 41, REGION, Horsens, N/A, Denmark

    Description

    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 Info

    Version 2.4

    Distribution

    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.

    Quantity

    43 sites have had access