Devices · Iterative Scopes, Inc.

SKOUT® system

Iterative Scopes, Inc. is listed for SKOUT® system (K240781). The FDA list gives April 19, 2024 as the date of the final decision. The lead panel is Gastroenterology-Urology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QNP as “Gastrointesinal Lesion Software Detection System”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240781

Official FDA database record

Date of final decision

April 19, 2024

Company on the FDA list

Iterative Scopes, Inc.

Lead panel

Gastroenterology-Urology

Primary product code

QNP

openFDA device name for the code

Gastrointesinal Lesion Software Detection System

Device class

2

Regulation number

876.1520

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary