Cleared Traditional

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

K031629 · Canon USA, Inc. · Ophthalmic
Jun 2003
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K031629 is an FDA 510(k) clearance for the CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 6, 2003, 10 days after receiving the submission on May 27, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K031629 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2003
Decision Date June 06, 2003
Days to Decision 10 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