Non-Mydriatic Retinal Camera, CR-45UAF
by Canon USA, Inc. 510(k)
Active
510(k) K911439
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911439 | Date17 Jun 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HKI
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1120
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Non-Mydriatic Retinal Camera, CR-45UAF is an AC-powered ophthalmic camera. It is designed to capture images of the retina for diagnostic purposes.
This device is supplied by Canon USA, Inc. and has received FDA 510(k) clearance under K911439. It is classified as a class 2 medical device.
Other devices from Canon USA, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the CR-45UAF retinal camera?
The CR-45UAF is an AC-powered ophthalmic camera specifically designed to capture images of the retina. These images are intended for use in diagnostic procedures.
What is the regulatory classification of this device?
The Canon CR-45UAF is classified as a class 2 medical device. It has received FDA 510(k) clearance under K911439.
Who is the manufacturer of the CR-45UAF?
This device is manufactured and supplied by Canon USA, Inc., based in Tokyo, Japan.