Cleared Traditional

RTVue XR OCT Avanti with AngioVue Software

K153080 · Optovue, Inc. · Ophthalmic

Feb 2016

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K153080 is an FDA 510(k) clearance for the RTVue XR OCT Avanti with AngioVue Software, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on February 11, 2016, 111 days after receiving the submission on October 23, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K153080 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 2015
Decision Date	February 11, 2016
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF