VS3-NE
VS3 Visionsense Camera Control Unit (CCU)
3manufacturers in China registered for this device type
3catalogue numbers in this listing
4510(k) clearances naming this product code
3recalls on this code
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 |
| Record published | 2024-11-11 |
| Record revised | 2024-09-12 (version 6) |
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 |
|---|---|---|
| 443-0001 | In distribution | |
| 443-0001 | In distribution | |
| 443-0001 | 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 |
| Open Field Fluorescence Imaging Head | Guangdong Optomedic Technologies, Inc. | 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 |
|---|---|
| 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.