Cleared Special

K111612 - DIGITAL RETINAL CAMERA

K111612 is an FDA 510(k) clearance for DIGITAL RETINAL CAMERA, manufactured by Canon, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Special 510(k) pathway after a 97-day FDA review.

K111612 · Canon, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
97d
Days
Class 2
Risk

K111612 is an FDA 510(k) clearance for the DIGITAL RETINAL CAMERA. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon, Inc. (Honkomagome, Bunkyo-Ku Tokyo, JP). The FDA issued a Cleared decision on September 14, 2011 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111612

510(k) Number K111612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2011
Decision Date September 14, 2011
Days to Decision 97 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 153
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K111612.
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
K113451 · Nidek Technologies Srl · May 2012
KOWA VX-20
K112330 · Kowa Co. , Ltd. · Feb 2012
NON-CONTACT TEAR FILM THERMOGRAGH
K111771 · United Integrated Services Co., Ltd. · Nov 2011
VISTA DIGITAL OPTHALMOSCOPE
K102412 · Eyequick.Llc · Jun 2011
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K110986 · Optomed OY · May 2011
RETCAM 3 OPTHALMIC IMAGING SYSTEM
K102859 · Clarity Medical Systems · Apr 2011
K111612 · DIGITAL RETINAL CAMERA
Download PDF FDA Summary Canon, Inc.