Optomed Aurora Full Set
The Optomed Aurora full set is an ophthalmic imaging system containing the Aurora camera, retinal module and anterior module. Trained personnel use its interchangeable optics to capture…
The Optomed Aurora full set is an ophthalmic imaging system containing the Aurora camera, retinal module and anterior module. Trained personnel use its interchangeable optics to capture images and video of the eye fundus, eye surface and surrounding areas for documentation and consultation.
The retinal module targets the fundus with infrared light and uses a white flash for image capture. The anterior module offers white and cobalt blue illumination, including fluorescent imaging of the eye surface.
Listed Item
Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.
Image Storage and Transfer
Images and videos are saved to a memory card. They can transfer automatically to a computer over WLAN or through a USB connection using the charging station. The station also charges the camera’s rechargeable lithium-ion battery.
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 | Optomed, Finland |
|---|---|
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K180378 |
| Record published | 2019-12-04 |
| Record revised | 2021-11-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60100635A | 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 |
|---|---|
| K180378 | 2018-04-05 |
| K163021 | 2017-04-11 |
| K132186 | 2013-12-18 |
| K110986 | 2011-05-16 |
| K092056 | 2009-10-01 |
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.