DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Nordicicemedical AS
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Attleboro, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LLZ

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . 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.