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FDA 510(k)

RTVue XR OCT Avanti with AngioVue Software

K-Number: K153080 · 2016-02-11

ApplicantOptovue, Inc.
Decision Date2016-02-11
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RTVue XR OCT Avanti with AngioVue Software is a medical device manufactured by Optovue, Inc.. It received FDA 510(k) clearance on 2016-02-11 under approval number K153080. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTVue XR OCT Avanti with AngioVue Software?

RTVue XR OCT Avanti with AngioVue Software is a medical device that received FDA 510(k) clearance on 2016-02-11. It is manufactured by Optovue, Inc.. The 510(k) number is K153080.

When was RTVue XR OCT Avanti with AngioVue Software approved by the FDA?

RTVue XR OCT Avanti with AngioVue Software received FDA 510(k) clearance on 2016-02-11, under approval number K153080.

What company makes RTVue XR OCT Avanti with AngioVue Software?

RTVue XR OCT Avanti with AngioVue Software is manufactured by Optovue, Inc..

What is the FDA product code for RTVue XR OCT Avanti with AngioVue Software?

The FDA product code for RTVue XR OCT Avanti with AngioVue Software is HLI.

Other Devices by Optovue, Inc.

K163475iVue K180660Avanti K222166SOLIX

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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