Skout System
The SKOUT system is software designed to detect potential colorectal polyps in real time during colonoscopy. It provides polyp location information to assist trained gastroenterologists…
The SKOUT system is software designed to detect potential colorectal polyps in real time during colonoscopy. It provides polyp location information to assist trained gastroenterologists during colorectal cancer screening or surveillance examinations in adults.
The filing says the system highlights portions of the colon where potential polyps are detected. It is intended to assist the gastroenterologist, who reviews suspected areas and determines whether a polyp is present.
Listed Item
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps. The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Detection Support
The FDA filing limits the system to white-light colonoscopy and states that it is not intended to replace full patient evaluation or serve as a primary interpretation or diagnosis.
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 | Iterative Scopes, Inc., United States |
|---|---|
| FDA product code | QNP |
| Device type | Gastrointesinal Lesion Software Detection System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1520 |
| 510(k) | K241508 |
| Record published | 2024-10-10 |
| Record revised | 2024-02-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 60 °C; Handling environment temperature 10 to 40 °C; Handling environment humidity 20 to 90 % RH; Storage environment humidity 20 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SKOUT210 | In distribution | |
| SKOUT200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GI Genius | Covidien LP | 5 |
| ColonPRO™ 4.0 | Linkverse SRL | 3 |
| 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 |
| EndoScreener | Chengdu Wision Medical Device Co., Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241508 | 2024-07-03 |
| K240781 | 2024-04-19 |
| K230658 | 2023-04-07 |
| K213686 | 2022-08-12 |
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.