K253664 is an FDA 510(k) clearance for the SKOUT system. This device is classified as a Gastrointesinal Lesion Software Detection System (Class II - Special Controls, product code QNP).
Submitted by Iterative Health (Cambridge, US). The FDA issued a Cleared decision on December 22, 2025, 32 days after receiving the submission on November 20, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1520. A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope..
| 510(k) Number | K253664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2025 |
| Decision Date | December 22, 2025 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QNP - Gastrointesinal Lesion Software Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1520 |
| Definition | A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope. |