COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM— 510(k) K040365

Name: FDA 510(k) clearance K040365
Creator: U.S. Food and Drug Administration
Published: 2004-04-28

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K040365 for COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM, Substantially Equivalent on 2004-04-28. Applicant: Barco N.V.. Device class: 2.

Clearance details

Applicant: Barco N.V.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2004-02-13
Decision date: 2004-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Barco N.V.

view all

K243307 — LCD Monitor (MDEC-2523)2024-12-13
K242008 — Coronis OneLook2024-08-02
K233693 — Nio Color 8MP (MDNC-8132)2023-12-11
K230520 — Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)2023-03-21
K213957 — Demetra Dermatoscope BDEM-012022-03-11

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.