Cleared Special

K102013 - DIGITAL RETINAL CAMERA

K102013 is an FDA 510(k) clearance for DIGITAL RETINAL CAMERA, manufactured by Canon Inc. -Medical Equipment Group. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Special 510(k) pathway after a 105-day FDA review.

K102013 · Canon Inc. -Medical Equipment Group · Ophthalmic device
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Oct 2010
Decision
105d
Days
Class 2
Risk

K102013 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. -Medical Equipment Group (Tachikawa-Shi, Tokyo, JP). The FDA issued a Cleared decision on October 29, 2010 after a review of 105 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. -Medical Equipment Group devices

FDA 510(k) Submission Details - K102013

510(k) Number K102013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2010
Decision Date October 29, 2010
Days to Decision 105 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
5d faster than avg
Panel avg: 110d · This submission: 105d
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 135
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K102013.
ISCREEN VISION SCREENER
K102651 · Iscreen Vision, Inc. · Jan 2011
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
K101861 · Truevision Systems, Incorporated · Dec 2010
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
K093071 · Fundus Photo, LLC · Nov 2010
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K101935 · Centervue S.P.A. · Oct 2010
DIGITAL RETINAL CAMERA CX-1
K092565 · Canon Components, Inc. · Mar 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207 · Topcon Corp. · Feb 2010