Cleared Traditional

K946058 - 60 FUNDUS CAMERA CF-60UV

K946058 is an FDA 510(k) clearance for 60 FUNDUS CAMERA CF-60UV, 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 87-day FDA review.

K946058 · Canon USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
87d
Days
Class 2
Risk

K946058 is an FDA 510(k) clearance for the 60 FUNDUS CAMERA CF-60UV. 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 February 3, 1995 after a review of 87 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 - K946058

510(k) Number K946058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date February 03, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
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 112
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K946058.
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
K963333 · Karl Storz Imaging, Inc. · Oct 1996
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
K955442 · Kowa Optimed, Inc. · Jan 1996
NON-MYDRIATIC RETINAL CAMERA
K941234 · Canon USA, Inc. · Jun 1995
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663 · Canon USA, Inc. · Feb 1994
CANDELA RETINAL CAMERA
K913314 · Candela Laser Corp. · Jan 1992
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · Canon USA, Inc. · Jun 1991