NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1— 510(k) K063539

Substantially Equivalent

Nordicicemedical AS

FDA 510(k) clearance K063539 for NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1, Substantially Equivalent on 2007-01-17. Applicant: Nordicicemedical AS.

Clearance details

Applicant: Nordicicemedical AS
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-11-24
Decision date: 2007-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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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.