Devices · Digestaid - Artificial Intelligence Development SA

Deep Capsule® (Deep Capsule US)

Digestaid - Artificial Intelligence Development SA is listed for Deep Capsule® (Deep Capsule US) (K250655). The FDA list gives March 12, 2026 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 QZF as “Gastrointestinal Capsule Endoscopy Analysis Software Device”: A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system. 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=K250655

Official FDA database record

Date of final decision

March 12, 2026

Company on the FDA list

Digestaid - Artificial Intelligence Development SA

Lead panel

Gastroenterology-Urology

Primary product code

QZF

openFDA device name for the code

Gastrointestinal Capsule Endoscopy Analysis Software Device

Device class

2

Regulation number

876.1540

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary