Recall Z-0934-2021— Brainreader ApS
Class II · Terminated
Class II FDA medical device recall by Brainreader ApS, initiated 2020-12-14, terminated 2021-08-12. It names one FDA 510(k) clearance: K140828. Product: 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..
- Recalling firm
- Brainreader ApS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-14
- Terminated
- 2021-08-12
- Firm location
- Horsens, Denmark
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.