Cleared Traditional

RetCam Envision

K203500 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Ophthalmic
Apr 2021
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K203500 is an FDA 510(k) clearance for the RetCam Envision, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on April 13, 2021, 134 days after receiving the submission on November 30, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K203500 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2020
Decision Date April 13, 2021
Days to Decision 134 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120