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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 the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2016-02-11 under 510(k) 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. The listed applicant is Optovue, Inc.. The 510(k) number is K153080.

When did RTVue XR OCT Avanti with AngioVue Software receive FDA 510(k) clearance?

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

Who is the listed applicant for RTVue XR OCT Avanti with AngioVue Software?

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 XR OCT Avanti with AngioVue Software?

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

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.

K222166SOLIXK180660AvantiK163475iVue

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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