Cellvizio® 100 Series (785nm)
The Cellvizio 100 series 785 nm system produces confocal images of internal tissue microstructure. Its fibre-optic probes are used in anatomical tracts, including the gastrointestinal and…
The Cellvizio 100 series 785 nm system produces confocal images of internal tissue microstructure. Its fibre-optic probes are used in anatomical tracts, including the gastrointestinal and respiratory tracts, reached through an endoscope or endoscopic accessories.
The F700-v2 system uses a laser emitting at 785 nm and optical filters adapted to that wavelength. Compatible Confocal Miniprobes transmit the imaging light and support image acquisition from tissue within the accessed tract.
Endoscopic Imaging
The system is used with endoscopic access and compatible probes to image tissue microstructure. The 785 nm configuration is distinct from earlier systems using 488 nm or 660 nm lasers.
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 | Mauna KEA Technologies, France |
|---|---|
| FDA product code | OWN |
| Device type | Confocal Optical Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K133466 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| 210-0031 | 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 |
| VS3 Iridium | Visionsense, Ltd. | 2 |
| SafeLight | Stryker GmbH | 2 |
| 1588 AIM | Stryker GmbH | 2 |
Showing 12 of 74. All products under Confocal Optical Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220477 | 2022-04-11 |
| K212322 | 2021-08-18 |
| K193416 | 2020-02-28 |
| K191144 | 2020-01-24 |
| K183640 | 2019-02-22 |
| K172844 | 2017-12-15 |
| K171345 | 2017-08-04 |
| K160416 | 2016-05-20 |
| K150831 | 2015-12-22 |
| K151593 | 2015-10-23 |
| K141358 | 2014-09-25 |
| K133466 | 2014-07-25 |
| K123676 | 2013-04-18 |
| K122042 | 2012-09-04 |
| K120208 | 2012-04-20 |
| K111047 | 2011-08-08 |
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.