Cleared Traditional

K123208 - DIGITAL RETINAL CAMERA

K123208 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 Traditional 510(k) pathway after a 158-day FDA review.

K123208 · Canon Inc. -Medical Equipment Group · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
158d
Days
Class 2
Risk

K123208 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 (Bunkyo-Ku, Tokyo, JP). The FDA issued a Cleared decision on March 19, 2013 after a review of 158 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Canon Inc. -Medical Equipment Group devices

FDA 510(k) Submission Details - K123208

510(k) Number K123208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2012
Decision Date March 19, 2013
Days to Decision 158 days
Submission Type Traditional
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
48d slower than avg
Panel avg: 110d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K123208.
IFUSION
K130656 · Optovue, Inc. · Jul 2013
TRC-50DX RETINAL CAMERA
K123101 · Topcon Medical Systems, Inc. · Jun 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289 · Topcon Corp. · May 2013
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
K123460 · Topcon Medical Systems, Inc. · Feb 2013
ICAM FUNDUS CAMERA
K122572 · Optovue, Inc. · Jan 2013
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K122481 · Tearscience, Inc. · Dec 2012