Cleared Special

SKOUT system

K251126 · Iterative Health · Gastroenterology & Urology

May 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K251126 is an FDA 510(k) clearance for the SKOUT system, 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 May 9, 2025, 28 days after receiving the submission on April 11, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1520.

Submission Details

510(k) Number	K251126 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2025
Decision Date	May 09, 2025
Days to Decision	28 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

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.