nordicBrainEx— 510(k) K163324

Substantially Equivalent

Nordicneurolab AS

FDA 510(k) clearance K163324 for nordicBrainEx, Substantially Equivalent on 2017-01-27. Applicant: Nordicneurolab AS.

Clearance details

Applicant: Nordicneurolab AS
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-11-25
Decision date: 2017-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bergen, NO

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.