OMNI-VUE 2 SYSTEM— 510(k) K130374

Name: FDA 510(k) clearance K130374
Creator: U.S. Food and Drug Administration
Published: 2013-08-29

Substantially Equivalent

Genesis Digital Imaging, Inc.

FDA 510(k) clearance K130374 for OMNI-VUE 2 SYSTEM, Substantially Equivalent on 2013-08-29. Applicant: Genesis Digital Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Genesis Digital Imaging, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2013-02-14
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Genesis Digital Imaging, Inc.

view all

K073062 — OMNI-VUE SYSTEM2008-03-10

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.