MODIFICATION TO NORDICICE SOFTWARE— 510(k) K090546

Substantially Equivalent

Nordicimaginglab AS

FDA 510(k) clearance K090546 for MODIFICATION TO NORDICICE SOFTWARE, Substantially Equivalent on 2009-06-08. Applicant: Nordicimaginglab AS.

Clearance details

Applicant: Nordicimaginglab AS
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-03-02
Decision date: 2009-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bergen, Hordaland, NO

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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.