Cleared Special

SKOUT® system (K230658) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230658 · Iterative Scopes, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
29d
Days
Class 2
Risk

K230658 is an FDA 510(k) clearance for the SKOUT® system. Classified as Gastrointesinal Lesion Software Detection System (product code QNP), Class II - Special Controls.

Submitted by Iterative Scopes, Inc. (Cambridge, US). The FDA issued a Cleared decision on April 7, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1520 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Iterative Scopes, Inc. devices

Submission Details

510(k) Number K230658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2023
Decision Date April 07, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QNP Gastrointesinal Lesion Software Detection System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - QNP Gastrointesinal Lesion Software Detection System

All 19
Devices cleared under the same product code (QNP) and FDA review panel - the closest regulatory comparables to K230658.
EW10-EC02 Endoscopy Support Program
K230751 · Fujifilm Corporation · Dec 2023
ME-APDS™
K223473 · Magentiq Eye, Ltd. · Jul 2023
GI Genius System 100 and GI Genius System 200
K231143 · Cosmo Artificial Intelligence - Ai, Ltd. · May 2023
SKOUT Software
K213686 · Iterative Scopes, Inc. · Aug 2022
EndoScreener
K211326 · Chengdu Wision Medical Device Co., Ltd. · Nov 2021
GI Genius
K211951 · Cosmo Artificial Intelligence - Ai, Ltd. · Jul 2021