K250655 is an FDA 510(k) clearance for the Deep Capsule® (Deep Capsule US). This device is classified as a Gastrointestinal Capsule Endoscopy Analysis Software Device (Class II - Special Controls, product code QZF).
Submitted by Digestaid - Artificial Intelligence Development SA (Gondomar, PT). The FDA issued a Cleared decision on March 12, 2026, 372 days after receiving the submission on March 5, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1540. A Gastrointestinal Capsule Endoscopy Analysis Software Device Is Used To Analyze Pre-recorded Capsule Endoscopy Videos Of The Gastrointestinal Tract That Are Suspected Of Containing Lesions. This Device Uses Software Algorithms To Identify Images And Areas Of Interest As Outputs To Aid The Clinician In Analyzing Suspected Lesions, For Clinician Review Of Device Outputs. The Device May Contain Hardware To Support Interfacing With A Capsule Imaging System..
| 510(k) Number | K250655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QZF — Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1540 |
| Definition | A Gastrointestinal Capsule Endoscopy Analysis Software Device Is Used To Analyze Pre-recorded Capsule Endoscopy Videos Of The Gastrointestinal Tract That Are Suspected Of Containing Lesions. This Device Uses Software Algorithms To Identify Images And Areas Of Interest As Outputs To Aid The Clinician In Analyzing Suspected Lesions, For Clinician Review Of Device Outputs. The Device May Contain Hardware To Support Interfacing With A Capsule Imaging System. |