510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Brainreader

Aalborg Nordjylland, DK

Brainreader appears in FDA device records in Aalborg Nordjylland, DK. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Brainreader in 2015.

Clearances by year, as a table
510(k) clearance decisions for Brainreader, by decision year
YearClearances
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K140828NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARELLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Brainreader, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30116573363011657336BrainreaderNiels Jernes Vej 10, Aalborg Nordjylland 9220 DK2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0934-2021Neuroreader 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain