FDA UDI
In Commercial Distribution
🇺🇸 United States
SKOUT system
DI: 00860010168400
·
Model: SKOUT200
·
Iterative Scopes, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SKOUT system
- Primary DI
- 00860010168400
- Version / Model
- SKOUT200
- Company Name
- Iterative Scopes, Inc.
- Labeler DUNS
- 080007054
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-23
- Public Version
- 2
- Public Version Date
- 2024-02-14
- Public Version Status
- Update
- Public Device Record Key
- 733aa0b9-e1c9-4a32-bc62-0b2097f0e44d
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | Gastroenterology, Urology | 876.1520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64688 | Endoscopic video image interpretive unit | An electrically-powered computing unit intended to analyse endoscopic video images to automatically detect and localize suspected abnormalities and lesions (e.g., polyps) in real-time. It interfaces with an endoscopic video image processing unit and display monitor, and will typically use artificial intelligence (AI)/deep learning software to identify abnormalities and overlay visual flags/markers on video images to highlight regions of interest to clinicians. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010168400 | GS1 |
Customer Contacts
- Phone
- 1-877-697-5688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity