NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM— 510(k) K042662

Name: FDA 510(k) clearance K042662
Creator: U.S. Food and Drug Administration
Published: 2004-11-22

Substantially Equivalent

Barco NV Barcoview

FDA 510(k) clearance K042662 for NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM, Substantially Equivalent on 2004-11-22. Applicant: Barco NV Barcoview. Device class: 2.

Clearance details

Applicant: Barco NV Barcoview
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2004-09-28
Decision date: 2004-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Barco NV Barcoview

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K042221 — CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM2004-12-30
K042942 — MGP 15 DICOM THEATER2004-11-22
K042660 — NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM2004-11-19
K042661 — NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM2004-11-19
K041508 — BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM2004-08-27

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.