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FDA 510(k)

OMNI-VUE 2 SYSTEM

K-Number: K130374 · 2013-08-29

ApplicantGenesis Digital Imaging, Inc.
Decision Date2013-08-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNI-VUE 2 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Digital Imaging, Inc.. It received FDA 510(k) clearance on 2013-08-29 under 510(k) number K130374. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-VUE 2 SYSTEM?

OMNI-VUE 2 SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-29. The listed applicant is Genesis Digital Imaging, Inc.. The 510(k) number is K130374.

When did OMNI-VUE 2 SYSTEM receive FDA 510(k) clearance?

OMNI-VUE 2 SYSTEM received FDA 510(k) clearance on 2013-08-29, under 510(k) number K130374.

Who is the listed applicant for OMNI-VUE 2 SYSTEM?

The FDA 510(k) record lists Genesis Digital Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNI-VUE 2 SYSTEM?

The FDA product code for OMNI-VUE 2 SYSTEM is LLZ.

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Other records listing Genesis Digital Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073062OMNI-VUE SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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