Cleared Traditional

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

K181016 · Welch Allyn, Inc. · Ophthalmic
Jul 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K181016 is an FDA 510(k) clearance for the Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 16, 2018, 90 days after receiving the submission on April 17, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K181016 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2018
Decision Date July 16, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NFJ — System, Image Management, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050