MODIFICATION TO FMRI HARDWARE SYSTEM— 510(k) K092253

Substantially Equivalent

Nordicneurolab

FDA 510(k) clearance K092253 for MODIFICATION TO FMRI HARDWARE SYSTEM, Substantially Equivalent on 2009-10-08. Applicant: Nordicneurolab.

Clearance details

Applicant: Nordicneurolab
Product code: Code LNH
Advisory panel: Radiology
Date received: 2009-07-28
Decision date: 2009-10-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Bergen, NO

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.