Cleared Traditional

K092565 - DIGITAL RETINAL CAMERA CX-1

K092565 is an FDA 510(k) clearance for DIGITAL RETINAL CAMERA CX-1, manufactured by Canon Components, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K092565 · Canon Components, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
210d
Days
Class 2
Risk

K092565 is an FDA 510(k) clearance for the DIGITAL RETINAL CAMERA CX-1. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon Components, Inc. (Lake Success, US). The FDA issued a Cleared decision on March 18, 2010 after a review of 210 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.

FDA 510(k) Submission Details - K092565

510(k) Number K092565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date March 18, 2010
Days to Decision 210 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 110d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K092565.
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
K093071 · Fundus Photo, LLC · Nov 2010
DIGITAL RETINAL CAMERA
K102013 · Canon Inc. -Medical Equipment Group · Oct 2010
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K101935 · Centervue S.P.A. · Oct 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207 · Topcon Corp. · Feb 2010
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
K090326 · Clarity Medical Systems · Nov 2009
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K092374 · Ophthalmic Imaging Systems · Nov 2009
K092565 · DIGITAL RETINAL CAMERA CX-1
Download PDF FDA Summary Canon Components, Inc.