Cleared Traditional

K980246 - NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM

K980246 is an FDA 510(k) clearance for 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 103-day FDA review.

K980246 · Canon USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
103d
Days
Class 2
Risk

K980246 is an FDA 510(k) clearance for the NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM. 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 May 6, 1998 after a review of 103 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. 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 USA, Inc. devices

FDA 510(k) Submission Details - K980246

510(k) Number K980246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1998
Decision Date May 06, 1998
Days to Decision 103 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
7d faster than avg
Panel avg: 110d · This submission: 103d
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 110
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K980246.
WINSTATION RETINAL IMAGER
K982689 · Ophthalmic Imaging Systems · Oct 1998
DISCAM DIGITAL IMAGING SYSTEM
K974535 · Marcher Enterprises, Ltd. · Aug 1998
OPHTHAVISION IMAGING SYSTEM
K980295 · Mrp Group, Inc. · May 1998
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
K980357 · Konan, Inc. · Apr 1998
RETINAL CUBE
K973950 · Applied Spectral Imaging , Ltd. · Dec 1997
NIDEK HANDY
K973218 · Nidek, Inc. · Nov 1997