NFC-600
The NFC-600 is a portable, noncontact retinal camera that captures, stores and displays colour fundus images. It uses near-infrared LED illumination to align with the retina and includes…
The NFC-600 is a portable, noncontact retinal camera that captures, stores and displays colour fundus images. It uses near-infrared LED illumination to align with the retina and includes automatic focusing, tracking, exposure and image capture functions.
The camera connects to an external PC or laptop through USB rather than containing an embedded computer. Proprietary software on that computer operates the device and provides tools to capture, view, retrieve and export ophthalmic images.
Image Output
The camera produces 12-megapixel colour images. Its imaging and computer connection support a portable arrangement in which image acquisition occurs at the camera and image management occurs on the connected computer.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Chongqing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Chongqing BIO Newvision Medical Equipment Ltd. | Chongqing | Chongqing | Manufacturer | 2 |
Record
| Listed by | Crystalvue Medical Corporation, Taiwan |
|---|---|
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K210197 |
| Record published | 2021-07-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NFC-600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 15 |
| Neolight | Neolight, LLC | 11 |
| Natus | Xltek | 6 |
| RetCam Envision | Natus Medical Denmark ApS | 6 |
| 3nethra | Forus Health Pvt.ltd., | 6 |
| iCam | Optovue, Inc. | 5 |
| iFusion | Optovue, Inc. | 5 |
| Canon Inc. | Canon Inc. | 4 |
| Camera, Ophthalmic, Ac-Powered | Chongqing Kanghuaruiming S&T Co., Ltd.. | 4 |
| 3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2) | Topcon Corp. | 3 |
| Retinal Camera TRC-50DX | Topcon Corp. | 3 |
| NON-Mydriatic Retinal Camera TRC-NW400 | Topcon Corp. | 2 |
Showing 12 of 123. All products under Camera, Ophthalmic, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210197 | 2021-04-13 |
| K182199 | 2019-01-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.