Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) 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. The listed applicant is Optovue, Inc.. The 510(k) number is K163475.

When did iVue receive FDA 510(k) clearance?

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

Who is the listed applicant for iVue?

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 iVue?

The FDA product code for iVue is OBO.

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.

K222166SOLIXK180660AvantiK153080RTVue XR OCT Avanti with AngioVue Software

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.

K253837SPECTRALIS 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 GmbHK241163SPECTRALIS with Flex ModuleHeidelberg 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.

↑