510(k) K250655
- Device
- Deep Capsule® (Deep Capsule US)
- Applicant
- Digestaid - Artificial Intelligence Development SA
- 510(k) number
- K250655
- Product code
- QZF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-12
- Date received
- 2025-03-05
- Regulation
- 876.1540
- Classification name
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Miguel Mascarenhas
- Address
- Rua Particular Carlos Fontes, 117, São Cosme Gondomar PT 4420-249 4420-249
FDA Registration Numbers#
- 3016544248
Source Documents#
Other 510(k) Records For Product Code QZF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230027 | NaviCam ProScan | Ankon Technologies Co., Ltd. | 2023-12-12 |