510(k) · Gastroenterology-Urology

SKOUT system

by Iterative Health

SKOUT system is an AI-enabled medical device from Iterative Health that the U.S. FDA cleared through 510(k) K251126 on May 9, 2025. Its lead review panel is Gastroenterology-Urology and its primary product code is QNP (Gastrointesinal Lesion Software Detection System).

See also FDA-cleared AI gastroenterology-urology devices in 2025, all FDA AI clearances in 2025, top gastroenterology-urology AI devices.

Key facts

Submission numberK251126
Pathway510(k)
Date of final decision
Company (FDA list)Iterative Health
Lead review panelGastroenterology-Urology
Primary product codeQNP — Gastrointesinal Lesion Software Detection System
Applicant (openFDA)Iterative Health
Applicant locationCambridge, MA, US
Device classClass 2
Regulation number21 CFR 876.1520
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. SKOUT system went through this pathway (K251126).

openFDA lists it as a Class 2 device under 21 CFR 876.1520. Class II devices are moderate risk and are subject to general and special controls.

Product code QNP covers 20 devices on the FDA AI list. By decision date, this device is #15 of 20 under that code. Iterative Health has 2 AI-enabled devices on the list, and the Gastroenterology-Urology panel accounts for 27 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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