510(k) DEN230027

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

December 12, 2023

Date Received

April 14, 2023

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Gastrointestinal Capsule Endoscopy Analysis Software Device

Device Class

Class II

Regulation Number

876.1540

Review Panel

GU

Submission Type

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.