NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM— 510(k) K042661

Substantially Equivalent

Barco NV Barcoview

FDA 510(k) clearance K042661 for NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM, Substantially Equivalent on 2004-11-19. Applicant: Barco NV Barcoview.

Clearance details

Applicant: Barco NV Barcoview
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-09-28
Decision date: 2004-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, 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.