Data / Medical devices / Denmark / Brainreader

Brainreader: FDA-registered device maker in Aalborg Nordjylland, Denmark, 1 510(k) clearance

Name: Brainreader FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Brainreader is registered with the FDA (registration 3011657336) in Aalborg Nordjylland, Denmark. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011657336
Address: Niels Jernes Vej 10, Aalborg Nordjylland, Denmark, 9220
Owner or operator: Brainreader A/S (10049047)
Roles: Specification developer
First device listed: April 7, 2015
Registered through: 2026
Brand names listed: Neuroreader®

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 4, 2015	K140828	NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE	LLZ	Substantially Equivalent	Brainreader Aps	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 14, 2020	86995	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.	The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.	accessdata.fda.gov

Compare with other makers

Updated February 4, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.