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Catalogue number Accessory to GI Genius, listed by Linkverse SRL, under Gastrointesinal Lesion Software Detection System. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Sichuan.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chengdu Wision Medical Device Co., Ltd. | Chengdu | Sichuan | Manufacturer | 1 |
Record
| Listed by | Linkverse SRL |
|---|---|
| FDA product code | QNP |
| Device type | Gastrointesinal Lesion Software Detection System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1520 |
| 510(k) | K231143 |
| Record published | 2023-08-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 14 to 104 °F; Storage environment humidity 20 to 90 % RH; Storage environment atmospheric pressure 75.3 to 101.3 KiloPascal; Handling environment temperature 50 to 104 °F; Handling environment humidity 20 to 90 % RH; Handling environment atmospheric pressure 75.3 to 101.3 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Accessory to GI Genius | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GI Genius | Covidien LP | 5 |
| ColonPRO™ 4.0 | Linkverse SRL | 3 |
| Skout system | Iterative Scopes, Inc. | 2 |
| Caddie | Odin Medical Limited | 2 |
| GI Genius™ Module 200 | Linkverse SRL | 1 |
| Fujifilm | Fujifilm Corporation | 1 |
| USB K-switch | Linkverse SRL | 1 |
| GI Genius™ Module 300 | Linkverse SRL | 1 |
| ColonPRO™ US | Linkverse SRL | 1 |
| GI Genius™ Module 100 | Linkverse SRL | 1 |
| Magentiq-Colo (ME-Apds) | Magentiq EYE Ltd | 1 |
| EndoScreener | Chengdu Wision Medical Device Co., Ltd. | 1 |
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.