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FDA 510(k)

iVue

K-Number: K163475 · 2017-06-09

ApplicantOptovue, Inc.
Decision Date2017-06-09
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

iVue is a medical device manufactured by Optovue, Inc.. It received FDA 510(k) clearance on 2017-06-09 under approval number K163475. 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 iVue?

iVue is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by Optovue, Inc.. The 510(k) number is K163475.

When was iVue approved by the FDA?

iVue received FDA 510(k) clearance on 2017-06-09, under approval number K163475.

What company makes iVue?

iVue is manufactured by Optovue, Inc..

What is the FDA product code for iVue?

The FDA product code for iVue is OBO.

Other Devices by Optovue, Inc.

K153080RTVue XR OCT Avanti with AngioVue Software K180660Avanti K222166SOLIX

Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

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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