nordicMEDiVA— 510(k) K243209

Name: FDA 510(k) clearance K243209
Creator: U.S. Food and Drug Administration
Published: 2024-10-22

Substantially Equivalent

Nordicneurolab AS

FDA 510(k) clearance K243209 for nordicMEDiVA, Substantially Equivalent on 2024-10-22. Applicant: Nordicneurolab AS. Device class: 2.

Clearance details

Applicant: Nordicneurolab AS
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-10-01
Decision date: 2024-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bergen, NO

Download summary PDF View on FDA.gov ↗

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More clearances from Nordicneurolab AS

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K251937 — nordicAudio (1.0)2026-03-20
K241608 — nordicMEDiVA2024-06-28
K232680 — fMRI Hardware System2023-12-13
K212720 — nordicDSC2022-03-03
K191032 — fMRI Hardware System2019-11-27

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.