OMNI-VUE 2 SYSTEM— 510(k) K130374

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..

Clearance details

Applicant: Genesis Digital Imaging, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-02-14
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, 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.