Ifusion
iFusion connects the iCam and iVue devices through a sliding bracket mechanism called the iShuttle. The filing describes this arrangement as a way to switch between the two devices. The…
iFusion connects the iCam and iVue devices through a sliding bracket mechanism called the iShuttle. The filing describes this arrangement as a way to switch between the two devices.
The iShuttle provides position adjustment for the iCam or iVue during use. The filing names iFusion as the device that interfaces with both systems.
Listed Item
iVue NR for iFusion USCFG 230V
Device Arrangement and Operation
The FDA filing says this interface enables operation of iCam and iVue from one computer unit. It also states that the software allows users to switch between the two programs on the same 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 | Optovue, Inc., United States |
|---|---|
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K130656 |
| Record published | 2020-08-24 |
| Record revised | 2020-06-05 (version 2) |
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 |
|---|---|---|
| iFusion | In distribution | |
| iFusion | In distribution | |
| iFusion | In distribution | |
| iFusion | In distribution | |
| iFusion | 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 |
| 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 |
| Visionix | Luneau Technology Operations | 2 |
Showing 12 of 123. All products under Camera, Ophthalmic, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130656 | 2013-07-03 |
| K122572 | 2013-01-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Optovue, Inc. | 510(k) number | 2017-07-27 | Class II | Other | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 326 devices | 2021-04-12 |
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.