IVUE, MODEL 100— 510(k) K091404

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K091404 for IVUE, MODEL 100, Substantially Equivalent on 2010-04-22. Applicant: Optovue, Inc.. Device class: 2.

Clearance details

Applicant: Optovue, Inc.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2009-05-12
Decision date: 2010-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Optovue, Inc.

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Recalls naming K091404

K-number listed on FDA's recall record

Z-0024-2013 — Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.Class II·Terminated·Optovue Inc.·20120907

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091404.

Data sourced from openFDA. This site is unofficial and independent of the FDA.