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FDA 510(k)

RTVUE

K-Number: K062552 · 2006-10-06

ApplicantOptovue, Inc.
Decision Date2006-10-06
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RTVUE is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2006-10-06 under 510(k) number K062552. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTVUE?

RTVUE is a medical device that received FDA 510(k) clearance on 2006-10-06. The listed applicant is Optovue, Inc.. The 510(k) number is K062552.

When did RTVUE receive FDA 510(k) clearance?

RTVUE received FDA 510(k) clearance on 2006-10-06, under 510(k) number K062552.

Who is the listed applicant for RTVUE?

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

What is the FDA product code for RTVUE?

The FDA product code for RTVUE is OBO.

Related Clinical Trials

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Other records listing Optovue, 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.

K222166SOLIXK180660AvantiK163475iVueK153080RTVue XR OCT Avanti with AngioVue SoftwareK130656IFUSIONK121739IVUE WITH NORMATIVE DATABASE

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Related Devices (Code: OBO)

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.

K261019ANTERIONHeidelberg Engineering GmbHK253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbH

Official Source

View on FDA Database →

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

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