EndoScreener
EndoScreener analyzes a colonoscopy video stream in real time and highlights regions of potential polyps. Licensed endoscopists use it during adult white-light colonoscopy; clinicians…
EndoScreener analyzes a colonoscopy video stream in real time and highlights regions of potential polyps.
Licensed endoscopists use it during adult white-light colonoscopy; clinicians review flagged areas and apply their own medical judgment.
Role and Limits
The software is intended to assist with polyp detection during colonoscopy. It is not intended to replace a full patient evaluation or to be relied upon to make or confirm a diagnosis. Physicians are responsible for reviewing identified areas and confirming whether a polyp is present using the image and their own medical judgment.
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 | Chengdu Wision Medical Device Co., Ltd., China |
|---|---|
| FDA product code | QNP |
| Device type | Gastrointesinal Lesion Software Detection System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1520 |
| Establishment | Manufacturer |
| 510(k) | K211326 |
| Record published | 2022-04-26 |
| Record revised | 2023-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WIPD01 | 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 |
| Footswitch | Linkverse SRL | 1 |
| ColonPRO™ US | Linkverse SRL | 1 |
| GI Genius™ Module 100 | Linkverse SRL | 1 |
| Magentiq-Colo (ME-Apds) | Magentiq EYE Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211326 | 2021-11-19 |
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.