Kowa VX-20
Kowa VX-20 is an ophthalmic camera for taking retinal photographs with or without pupil dilation. It offers mydriatic and non-mydriatic imaging modes, allowing retinal images to be captured…
Kowa VX-20 is an ophthalmic camera for taking retinal photographs with or without pupil dilation. It offers mydriatic and non-mydriatic imaging modes, allowing retinal images to be captured under either condition.
Its imaging modes also include fluorescein angiography, red-free photography and fundus autofluorescence angiography. The camera has a built-in image filing function, and stored retinal images can be viewed on its LCD monitor.
Listed Item
The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
Image Transfer
USB ports and an Ethernet port allow captured images to be transferred to an external device. These connections provide a route for moving images out of the camera’s internal filing system.
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 | Kowa Co., Ltd., Japan |
|---|---|
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| 510(k) | K112330 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -15 to 55 °C; Handling environment humidity 30 to 90 % RH; Handling environment temperature 10 to 35 °C; Storage environment humidity 10 to 95 % RH |
| Sizes | Height 720 mm; depth 540 mm; width 390 mm; weight 39 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K9L56BK | Height 720 mm | 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 |
|---|---|
| K191945 | 2019-09-10 |
| K190573 | 2019-06-04 |
| K112330 | 2012-02-16 |
| K101628 | 2011-01-26 |
| K091098 | 2009-08-07 |
| K091683 | 2009-07-02 |
| K083387 | 2009-01-16 |
| K082767 | 2008-10-21 |
| K080681 | 2008-04-04 |
| K062021 | 2006-11-01 |
| K062356 | 2006-09-27 |
| K053026 | 2005-11-10 |
| K050271 | 2005-11-03 |
| K043213 | 2005-10-06 |
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.