Cleared Traditional

K031629 - CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

K031629 is an FDA 510(k) clearance for CANON NON-MYDRIATIC RETINAL CAMERA, manufactured by Canon USA, Inc.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K031629 · Canon USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
10d
Days
Class 2
Risk

K031629 is an FDA 510(k) clearance for the CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 6, 2003 after a review of 10 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Canon USA, Inc. devices

FDA 510(k) Submission Details - K031629

510(k) Number K031629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date June 06, 2003
Days to Decision 10 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 faster than avg
Panel avg: 110d · This submission: 10d
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.
KENT DONOHUE

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 110
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K031629.
VISCUCAM C DIGITAL CAMERA
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DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K041546 · Canon, Inc. · Jun 2004
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · Nidek, Inc. · Apr 2002
DIGISCOPE OPHTHALMIC CAMERA
K990205 · Eye Tel Imaging, Inc. · Mar 1999
WINSTATION RETINAL IMAGER
K982689 · Ophthalmic Imaging Systems · Oct 1998