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
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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.

View all Canon, Inc. devices

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 99
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