DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE— 510(k) K111385

Name: FDA 510(k) clearance K111385
Creator: U.S. Food and Drug Administration
Published: 2012-01-30

Substantially Equivalent

Qubyx Limited

FDA 510(k) clearance K111385 for DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE, Substantially Equivalent on 2012-01-30. Applicant: Qubyx Limited. Device class: 2.

Clearance details

Applicant: Qubyx Limited
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2011-05-17
Decision date: 2012-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nice, FR

Download summary PDF View on FDA.gov ↗

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K131601 — DELL U3014 WITH QUBYX PERFECTLUM BUNDLE2014-07-07

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.