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FDA 510(k)

OMNI-VUE SYSTEM

K-Number: K073062 · 2008-03-10

ApplicantGenesis Digital Imaging, Inc.
Decision Date2008-03-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNI-VUE 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 2008-03-10 under 510(k) number K073062. 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 SYSTEM?

OMNI-VUE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-10. The listed applicant is Genesis Digital Imaging, Inc.. The 510(k) number is K073062.

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

OMNI-VUE SYSTEM received FDA 510(k) clearance on 2008-03-10, under 510(k) number K073062.

Who is the listed applicant for OMNI-VUE 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 SYSTEM?

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

Related Clinical Trials

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.

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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.

K130374OMNI-VUE 2 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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