Cleared Traditional

Altris IMS

K232088 · Altris, Inc. · Ophthalmic

Jul 2023

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K232088 is an FDA 510(k) clearance for the Altris IMS, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Altris, Inc. (Chicago, US). The FDA issued a Cleared decision on July 31, 2023, 18 days after receiving the submission on July 13, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K232088 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2023
Decision Date	July 31, 2023
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF