FDA UDI
In Commercial Distribution
🇺🇸 United States
NaviCam ProScan AI Software
DI: 00810164590275
·
Model: SB-US-2025
·
ANX ROBOTICA CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NaviCam ProScan AI Software
- Primary DI
- 00810164590275
- Version / Model
- SB-US-2025
- Catalog Number
- SB-US-2-25
- Company Name
- ANX ROBOTICA CORP
- Labeler DUNS
- 024972857
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-16
- Public Version
- 1
- Public Version Date
- 2026-02-24
- Public Version Status
- New
- Public Device Record Key
- 898ecfcb-1e21-4c53-b24e-f5dda4a3177d
Device Description
The NaviCam ProScan AI Software is used with the NaviCam SB System with ESView to identify abnormalities of the small bowel to reduce reading time by the physician.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| QZF | Gastrointestinal Capsule Endoscopy Analysis Software Device | Gastroenterology, Urology | 876.1540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64419 | Endoscopic video image interpretive software | An interpretive software program intended to be used to analyse endoscopic video images to detect and localize suspected abnormalities (e.g., polyps) in real-time or post-endoscopy [traditional or capsule endoscopy]; it may in addition be intended to differentiate lesions and/or produce a probability score (e.g., neoplastic versus non-neoplastic). It is intended to be used on an off-the-shelf computerized device (e.g., laptop, smartphone), interface with an endoscopic video image processing unit, and will typically apply artificial intelligence (AI)/deep learning techniques to identify abnormalities and overlay visual flags on video images displayed by a monitor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810164590275 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN230027 | 000 |