Open Field Fluorescence Imaging Head
Open Field Fluorescence Imaging Head is the handheld or arm-mounted camera component of the FloNavi system. It illuminates tissue with near-infrared light for ICG fluorescence imaging or…
Open Field Fluorescence Imaging Head is the handheld or arm-mounted camera component of the FloNavi system. It illuminates tissue with near-infrared light for ICG fluorescence imaging or white light for color imaging.
Its cameras capture the illuminated field and send video to the separate image-processing unit for display or recording. Controls on the head or processor adjust system operation.
Imaging Applications
With ICG used according to its labeling, the system visualizes blood flow and tissue perfusion during specified surgical procedures. Interstitial ICG supports lymphatic vessel and node imaging. Components are reusable, supplied nonsterile and require cleaning and low-level disinfection before and after use.
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Wuxi Hisky Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Guangdong Optomedic Technologies, Inc., China |
|---|---|
| FDA product code | OWN |
| Device type | Confocal Optical Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K230407 |
| Record published | 2024-03-25 |
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 |
|---|---|---|
| OPTO-CHD3100H | In distribution | |
| OPTO-CHD314KE | In distribution | |
| OPTO-CHD3100E | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VS3-IR | Visionsense, Ltd. | 22 |
| Confocal Microprobe Imaging System | Wuxi Hisky Medical Technologies Co., Ltd. | 16 |
| Confocal Optical Imaging | Karl Storz GmbH & Co. KG | 13 |
| Hopkins | Karl Storz GmbH & Co. KG | 4 |
| AIM (Advanced Imaging Modality) | Stryker GmbH | 4 |
| VS3-NE | Visionsense, Ltd. | 3 |
| Cellvizio® 100 series (488nm) | Mauna KEA Technologies | 3 |
| Photonvue | Fluoptics SAS | 2 |
| VS3 Iridium | Visionsense, Ltd. | 2 |
| SafeLight | Stryker GmbH | 2 |
| 1588 AIM | Stryker GmbH | 2 |
| Fluocase 800 | Fluoptics SAS | 2 |
Showing 12 of 74. All products under Confocal Optical Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230407 | 2023-07-17 |
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.