VS3 Iridium
The VS3 Iridium miniature microscope supplies visible and near-infrared fluorescence imaging during open surgery. It forms part of the VS3 Iridium visualization system with imaging hardware…
The VS3 Iridium miniature microscope supplies visible and near-infrared fluorescence imaging during open surgery. It forms part of the VS3 Iridium visualization system with imaging hardware and processing software. The system captures white-light and fluorescence images in parallel for display to the surgeon.
The 785 nm configuration can excite indocyanine green or pafolacianine, used according to each drug’s labeling. After intravenous ICG, imaging can visualize vessels, blood flow and tissue perfusion. Pafolacianine imaging displays tissue that has taken up the administered drug.
Listed Item
VS3 Iridium – Miniature Microscope, 785nm (MMS-IR)
Imaging and Recording
An infrared camera detects emitted fluorescence, with software supporting qualitative and quantitative intensity measurement. Procedures may be recorded, stored on removable media and replayed. Lymphatic imaging after interstitial ICG is indicated for the endoscope configuration, distinct from the miniature microscope described here.
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 | Visionsense, Ltd., United States |
|---|---|
| FDA product code | OWN |
| Device type | Confocal Optical Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K223020 |
| Record published | 2024-11-11 |
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 |
|---|---|---|
| 465-0011RFB | In distribution | |
| 175-0012RFB | 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 |
| Open Field Fluorescence Imaging Head | Guangdong Optomedic Technologies, Inc. | 3 |
| Cellvizio® 100 series (488nm) | Mauna KEA Technologies | 3 |
| Photonvue | Fluoptics SAS | 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 |
|---|---|
| K223020 | 2022-10-28 |
| K210265 | 2021-11-22 |
| K152204 | 2015-10-28 |
| K150018 | 2015-06-17 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-10-17 | Class II | Under Investigation by firm | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. | 205 units: 94 units OUS; 111 units US |
| 2022-10-17 | Class II | Under Investigation by firm | XXX | 34 units: 15 units OUS; 19 units US |
| 2022-10-17 | Class II | Under Investigation by firm | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. | 204 units: 93 units OUS ; 111 units US |
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.